ICQ Consultants is hiring for multiple positions across the country. Check out our Indeed Page and our GlassDoor Page and apply for one of our jobs to work for a great company today! Use our Careers Page to apply for general consideration or any of our open positions and an ICQ Recruiter will reach out to you.
Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.
https://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.png00Ashley Farleyhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngAshley Farley2018-11-30 12:06:292020-03-04 00:31:05ICQ Consultants is Hiring!
The 2018 ISPE Biopharmaceutical Manufacturing Conference focuses on the quickly evolving science of biologics manufacturing for new modalities. From leveraging existing capacity with novel processes, to implementing new and emerging technologies, this conference will bring together experts and leaders to ensure the Biomanufacturing industry successfully prepares to manufacture these novel medicines to deliver on our promise of supplying life changing medicines to patients across the globe. ICQ’s Michael Bogan and Michael Gatta will be in attendance. Don’t forget to register to attend!
Please stop in and meet the team from ICQ at Booth 307 at this years 2018 ISPE Biopharmaceutical Manufacturing Conference held from December 10th through the 12th at the Hyatt Regency Huntington Beach in Huntington Beach, CA.
ICQ Consultants continues to grow….
ICQ Consultants continues to expand, hiring for several new positions in Greater Boston, Greater Baltimore, and Greater San Francisco Areas. If you are considering a career change, we would love to hear from you. Visit our Career page today!
Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.
https://www.icqconsultants.com/wp-content/uploads/2018/08/headergood.jpg127635Ashley Farleyhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngAshley Farley2018-11-29 12:34:362020-03-04 00:31:05ICQ will be attending the 2018 ISPE Biopharmaceutical Manufacturing Conference in CA
In the pharmaceutical industry utilities sampling is done for a number of reasons such as regulatory requirements, quality control, process control, investigational purposes, diagnostic purposes, or Test Method Validation to name a few. Therefore it is important to understand what a sample is and why they are important.
Simply put, the purpose of sampling is to collect a small representative fraction of a much larger lot that accurately represents the composition of the lot. The sampling process should not modify or change the collected sample in any way. However in many cases this is a practically impossible proposition as all sampled utilities come into contact with air and containers during the sampling process. Sample handling concerns can be reduced and sometimes eliminated altogether by monitoring quality parameters using in-line, on-line, or at-line monitors. Quality attributes most commonly monitored are microbiological and endotoxin varieties, Total Organic Carbon (TOC) and conductivity. Unfortunately, many times a quality attribute of interest cannot be analyzed by such an instrument as previously described. In these cases a sample must be taken from the utility stream and evaluated off-line.
Sampling effectively is of the highest importance to the success of any pharmaceutical critical utility system. However, when it comes to sampling there is not much regulatory guidance. So collecting a representative sample from a utility system can be a difficult and complex process. Inaccuracies may be introduced in any number of ways such as:
environmental conditions
sample valve design
sample point location
procedure, container type
sample handling, sample storage and transport
The effect of these aspects is common and occurs throughout industry. As a result, errors due to sampling happen frequently. To mitigate sampling errors establish good practices by improving upon:
How you determine sampling locations
Developing sampling plans
Sample valve designs
Sampling Techniques
Handling Samples
Training for personnel performing the sampling
During a particular startup, renovations in the supporting QC laboratory areas were also ongoing. Unbeknownst to the startup team, sterility samples were stored and manipulated in a non-controlled space adjacent to the laboratory due to space constraints. When sample failures were noticed, an investigation of all the above listed criteria were performed. Finally, the space and lack of controls were identified and found to be the root cause of the failures. Communication of all “non-ordinary” aspects of a project is essential to minimize risk and work towards the successful and timely completion of sampling.
Improper sampling can be responsible for creating Out Of Specification (OOS) data and prompting investigations into a system that is actually providing suitable quality. Or conversely, improper sampling could create a more dangerous situation where the quality is in fact OOS, but the data falsely indicates that the quality is acceptable. In either instance, there could be adverse effect on company image, budget, production, integrity, and regulatory accountability, all brought about from improper sampling.
So get smart about your utility sampling!
Reference: ISPE Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Written By: Nathan Roberge, Consultant III
Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.
https://www.icqconsultants.com/wp-content/uploads/2017/06/cropped-4.png120120Ashley Farleyhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngAshley Farley2018-11-16 12:16:332020-03-04 00:31:05Getting Smart with Utilities Sampling
The 2018 ISPE Annual Meeting & Expo is a four day event for professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services, suppliers, and regulatory professionals. The expo will feature an extensive expo hall with more than 300 companies in attendance. There will be two days of training plus an array of workshops offered. Don’t forget to register to attend!
Please stop in and meet the team from ICQ at booth 1106 at this years 2018 ISPE Annual Meeting & Expo held from November 4th through the 7th at the Pennsylvania Convention Center in Philadelphia, PA.
ICQ Consultants continues to grow….
ICQ Consultants continues to expand, hiring for several new positions in Greater Boston, Greater Baltimore, and Greater San Francisco Areas. If you are considering a career change, we would love to hear from you. Visit our Career page today!
Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.
https://www.icqconsultants.com/wp-content/uploads/2018/08/headergood.jpg127635Ashley Farleyhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngAshley Farley2018-10-25 12:02:082020-03-04 00:31:05ICQ will be attending the 2018 ISPE Annual Meeting & Expo in PA
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
RESPONSIBILITIES
Manage the automation & construction project scope including budgeting, project management, resource allocation, integration, validation, data migration, training, SOPs, IT standards and system infrastructure needs to ensure a successful deployment into production. Oversee documentation of system requirements, functional requirements, technical specifications, and testing protocols using industry standards and the latest GAMP guidelines.
Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
Customarily and regularly exercises discretionary and independent judgment in performing the job.
Participate in training to ensure continued accreditation.
Maintain a safe working environment for self, team members and clients operational or administrative staff.
Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
REQUIRED EXPERIENCE
Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
Must be a self-starter, detail oriented and able to work independently with minimal supervision.
Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
REQUIRED SKILLS
3 to 5 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
Project management experience with business and systems analysis, 21 CFR Part 210, 211, 820 and 11, EudraLex Annex 11, ISO, and other GxP computer system validation (CSV), technical practice management, application development, and pharmaceutical clinical liaison.
GxP experience in managing the analysis, implementation, and validation of hardware and software solutions for the life sciences industry.
GxP experience in managing the analysis, implementation, and validation of hardware and software solutions for the life sciences industry.
Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
Manage stakeholder expectations, address user, functional, design requirements, and configuration specification; mitigate validation issues, quality on in the project. Employ industry best practices and processes.
Please note that only local candidates will be considered.
Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.
Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.
The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:
Automatic Job Notifications once the portal matches your skills and competencies to any of the jobs posted.
Increased Flexibility is
provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
Transparent Process lets the candidate track their job application throughout the entire process.
Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better career.
Register with ICQ and create your profile
Login to your profile
View all current job openings
Complete our custom skills matrix
Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
RESPONSIBILITIES
Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
Customarily and regularly exercises discretionary and independent judgment in performing the job.
Participate in training to ensure continued accreditation.
Maintain a safe working environment for self, team members and clients operational or administrative staff.
Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
REQUIRED EXPERIENCE
Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
Must be a self-starter, detail oriented and able to work independently with minimal supervision.
Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
REQUIRED SKILLS
5 plus years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
Experience writing protocols, performing execution for processes, equipment and utilities used in the Biotech or Pharmaceutical Industry.
Direct experience within the following areas; Computer System Validation (CSV), Data Integrity, Standard Operating Procedure (SOP), Change Control, Deviations, Master Validation Plans, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM), Data Analysis, Process Automation System (PAS), Enterprise System single use technologies.
Please note that only local candidates will be considered.
Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.
Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.
The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:
Automatic Job Notifications once the portal matches your skills and competencies to any of the jobs posted.
Increased Flexibility is
provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
Transparent Process lets the candidate track their job application throughout the entire process.
Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better career.
Register with ICQ and create your profile
Login to your profile
View all current job openings
Complete our custom skills matrix
Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.
https://www.icqconsultants.com/wp-content/uploads/2018/08/headergood.jpg127635Cassie Pritchardhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngCassie Pritchard2018-10-15 13:46:482020-03-04 00:31:05Job Posting: Computer System Validation (CSV), Greater Baltimore Area
The American Pharmaceutical Outsourcing Summit is designed to provide pharma outsourcing executives with current trends, strategic insights and best practices in manufacturing, outsourcing, capacity management, quality assurance, quality control, regulatory compliance, operation excellence, supply chain, and logistics. Network with over 150 of your peers as we explore strategies to maximize efficiency while remaining compliant in an ever-evolving environment.
Michael Gatta, Principal of ICQ Consultants will be hosting a round table discussion: “Challenges to Maintain Consistency of Validation Practices from the Operating Company to the CMO.”
Please stop in and meet the team from ICQ at booth 16 at this years American Pharma Outsourcing Summit held on October 2nd and 3rd at the Crowne Plaza Hotel in Cherry Hill, NJ.
ICQ Consultants continues to grow….
ICQ Consultants continues to expand, hiring for several new positions in Greater Boston, Greater Baltimore, and Greater San Francisco Areas. If you are considering a career change, we would love to hear from you. Visit our Career page today!
Join our network, follow us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants.
https://www.icqconsultants.com/wp-content/uploads/2018/08/headergood.jpg127635Mike Gattahttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngMike Gatta2018-09-28 12:02:502020-03-04 00:31:05ICQ will be attending the American Pharma Outsourcing Summit 2018 at the Crown Plaza Hotel, Cherry Hill, NJ
Thank you to everyone for stopping by and visiting with ICQ at the 2018 ISPE Product Show, it was great to see new faces and re-connect with old friends. Congratulations to the winners of our giveaways, we look forward to connecting with you all again!
https://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.png00Ashley Farleyhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngAshley Farley2018-09-28 09:24:352020-03-04 00:31:05Thank you for visiting!
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries.
RESPONSIBILITIES
Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
Customarily and regularly exercises discretionary and independent judgment in performing the job.
Participate in training to ensure continued accreditation.
Maintain a safe working environment for self, team members and clients operational or administrative staff.
Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
REQUIRED EXPERIENCE
Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
Must be a self-starter, detail oriented and able to work independently with minimal supervision.
Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
REQUIRED SKILLS
2 to 6 years of Project Management (PM) with experience in Bio-process operations.
Experience in scheduling, budgeting, planning, resource loading and overall oversight for the execution of CQV projects for lab processes, equipment and utilities process used in the Biotech or Pharmaceutical Industry.
Direct experience within the following areas; Project management (PM), P6, Installation and Operational Qualification (IQ, OQ) protocols, Validation, Standard Operating Procedure (SOP), Change Control, Data Analysis, single use technologies.
Please note that only local candidates will be considered.
Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.
Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.
The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:
Automatic Job Notifications once the portal matches your skills and competencies to any of the jobs posted.
Increased Flexibility is provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
Transparent Process lets the candidate track their job application throughout the entire process.
Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better career.
Register with ICQ and create your profile
Login to your profile
View all current job openings
Complete our custom skills matrix
Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.
https://www.icqconsultants.com/wp-content/uploads/2018/08/headergood.jpg127635Cassie Pritchardhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngCassie Pritchard2018-09-20 11:47:262020-03-04 00:31:05Job Posting: Project Management (PM), Greater Boston Area
EDUCATION & EXPERIENCE REQUIREMENTS
B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES
Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, budgetary and quality expectations of the client.
Customarily and regularly exercises discretionary and independent judgment in performing the job.
Participate in training to ensure continued accreditation.
Maintain a safe working environment for self, team members and clients operational or administrative staff.
Other tasks in alignment with your skills and competencies as required by the project, client and/or management.
REQUIRED EXPERIENCE
Must have excellent organizational, verbal and written communication skills; with demonstrated ability to efficiently and effectively communicate with cross-functional teams and management on recommended course of action, with minimal assistance.
Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project (as needed).
Must be a self-starter, detail oriented and able to work independently with minimal supervision.
Excellent troubleshooting skills; ability to react quickly to understand and solve problems.
REQUIRED SKILLS
2 to 6 years of Commissioning, Qualification and/or Validation (CQV) with experience in Bio-process operations.
Experience writing protocols, performing temperature mapping studies for controlled temperature units (CTU’s) used in the Biotech or Pharmaceutical Industry.
Direct experience within the following areas; Computer System Validation (CSV), Data Integrity, Standard Operating Procedure (SOP), Change Control, Data Analysis, Deviations, Master Validation Plans, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM), single use technologies.
Please note that only local candidates will be considered.
Apply online with the ICQ applicant sourcing platform. This platform is an engineered program designed to improve the candidate sourcing process, and will ultimately provide value to our employees, prospective candidates and clients alike.
Our Applicant Sourcing Platform provides direct access for candidates to seamlessly search for jobs, identify their industry specific skills and competencies, apply for jobs, and review their application status through the entire sourcing process.
The ICQ Applicant Sourcing Platform and associated career portal provides so many benefits to our candidates:
Automatic Job Notifications once the portal matches your skills and competencies to any of the jobs posted.
Increased Flexibility is provided since you can identify your availability and the system will notify you prior to that time to request updated profile information.
Increased Visibility and Exposure to all open positions and clients. Clients can view reports with your qualifications that match their job requirements.
Transparent Process lets the candidate track their job application throughout the entire process.
Visit the ICQ Applicant Sourcing Platform today start your journey to a new and better career.
Register with ICQ and create your profile
Login to your profile
View all current job openings
Complete our custom skills matrix
Join our network, follow us, like us and share this on LinkedIn, Google +, Twitter and Facebook so you can see other new and exciting news and discussions being posted by ICQ Consultants. Or visit our website and get and in depth view of what we are all about: http://icqconsultants.com.
https://www.icqconsultants.com/wp-content/uploads/2018/08/headergood.jpg127635Cassie Pritchardhttps://www.icqconsultants.com/wp-content/uploads/2023/01/icq-ellab-logo-300x81.pngCassie Pritchard2018-09-10 14:40:322020-03-04 00:31:05Job Posting: Controlled Temperature Unit (CTU), Greater Boston Area.
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ICQ Consultants is hiring for multiple positions across the country. Check out our Indeed Page and our GlassDoor Page and apply for one of our jobs to work for a great company today! Use our Careers Page to apply for general consideration or any of our open positions and an ICQ Recruiter will reach out to you.
in-line, on-line, or at-line monitors. Quality attributes most commonly monitored are microbiological and endotoxin varieties, Total Organic Carbon (TOC) and conductivity. Unfortunately, many times a quality attribute of interest cannot be analyzed by such an instrument as previously described. In these cases a sample must be taken from the utility stream and evaluated off-line.
skills and competencies to any of the jobs posted.
Thank you to everyone for stopping by and visiting with ICQ at the 2018 ISPE Product Show, it was great to see new faces and re-connect with old friends. Congratulations to the winners of our giveaways, we look forward to connecting with you all again!
