Considering a career change? ICQ is recruiting Process Engineers in Raleigh – Durham, NC.

If you are considering a career change, we would love to hear from you.  ICQ is actively recruiting highly motivated professionals to join our team.  We currently have opportunities available in the Research Triangle Park area of Raleigh Durham, NC.

ICQ offers some of the most competitive benefits and wages in our segment of service providers which include the following:

    • Short term / Long Term Disability – Paid 100% by ICQ
    • Life insurance – Paid 100% by ICQ
    • Tufts Health Insurance, Dental and Vision Plan – Paid 100% by ICQ
    • Paid time off for Holidays, Sick Time and Vacation
    • 401K with a 100% match to the first 4%

Positions report to the assigned manager and applicants are responsible for developing and executing protocols, including test functions, calibration, and sampling.  Must maintain compliance with the company’s Standard Operating Procedures and Policies.

EDUCATION/EXPERIENCE REQUIREMENTS

  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving in one or more of the following:
    • 3 to 5 years QC Lab Validation Experience.
    • 2 to 5 years Computer System Validation (Process Automation)
    • 2 to 5 years Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

RESPONSIBILITIES

  • Develop and execute validation plans, test plans, validation protocols, and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of validation team, or independently to develop protocols and procedures, execute same including test functions, sampling, and calibration.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.

DESIRED SKILLS AND EXPERIENCE

  • QC Lab Commissioning/Qualification/Validation
  • Computer System Validation (Automation – Delta V)
  • Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must

Only local candidates will be considered.

If you are interested in learning more about current opportunities, contact us directly at [email protected]

 

ICQ Consultants Announcement: Paul Provencal joins ICQ Consultants as Director of Sales and Commercial Operations.

P2As we embark into a new year we already see many opportunities for ICQ Consultants. In the past 10 years we have achieved considerable growth and understand that to sustain the current business, we need to continue our relentless focus on attracting top talent to directly support our clients so they can meet their goals in serving their patients. So, with our continued growth, we realize the need to attract additional top talent to compliment our management team and would like to welcome Paul Provencal to ICQ.

Paul is a very thoughtful, experienced and approachable technical professional that shares our common goals to focus on long term relationships with our clients and present a higher level of services. Paul has proven capabilities performing at a high level with a technical background in manufacturing, commissioning, qualification, validation, and management. In addition to his hands on experience Paul has several years of successfully and actively working in sales within the life science industry. Paul comes to ICQ Consultants as our Director of Sales and Commercial Operations.

Please join me in welcoming Paul to our team as he will be instrumental in the continued success of ICQ!

Temperature Mapping 101

58d17f22d349f95f008b5dfa-gifTemperature mapping is essential for working with temperature sensitive products such as food and pharmaceuticals. Its vital for verifying temperature controlled units/ areas such as fridges, freezers , cold rooms and warehouses. Temperature mapping is the process of using  probes to aggregate data of a temperature fluctuations of a controlled system due to various changes e.g open doors and product stored. The true purpose of temperature mapping is to find the place within the storage unit the greatest difference in temperature to assess way to fix/adjust the units setpoints to achieve the appropriate temperature. This locations is considered a worst case location. In the pharmaceutical/food industry it’s common to have an external probe with a sheath or sand in the worst case location.  The buffer is used to mimic packaging of the product albeit drugs or food. These external monitoring probes are usually connected to a BAS (Building Automation System) / PCS (Process Control System)  to monitors and alarm when the unit is out of tolerance. This is essential for a contingency plan if the unit were to Emergency_Lightfail and contents within storage container can be moved to an emergency location. Make sure to check back of other events and blogs for Integrated Commission and Qualification Inc.

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Written By: Joel Mowatt, Engineer II

ICQ Consultants Corp.

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ICQ Quarterly Newsletter

Please click the link below to enjoy our latest Quarterly Newsletter.  Be sure to check out all the added links!

ICQ_2017-10_Newsletter

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Join ICQ at the 26th Annual ISPE Product Show

producticqISPE will be hosting their 26th Annual Product Show located at Gillette Stadium on October 4th this year.  This event is a great networking opportunity with many available educational seminars.  Registration, parking and food are free gillette-stadium-logofor all attendees.  This event begins at 8:30 A.M. with breakfast and coffee networking and ends at 9:30 P.M. with an after-show networking social.  ICQ Consultants will be located at booth W27 during the exhibit hall hours, located in the west hall against the stadium windows.  There is still time to register for this event and see below for some helpful links!  ICQ looks forward to seeing you there, please stop by and say hello.ispe-logo

 

 

Directions to Gillette Stadium

Registration

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Visit ICQ at Biotech Week Boston

BWB_banners_July24-2017_twitter_exhibiting.pngICQ Consultants will be attending this years Biotech Week Boston.  Biotech Week Boston is a festival of leading events spanning the drug development value chain.  This unique festival of events includes scientific conferences, structured partnering, CEO keynotes, an awards party, a celebration of science and a little bit of rock and roll.  ICQ will be attending all exhibiting hours from Tuesday September 26th through Thursday September 28th.  This event will be held at the Hynes Convention Center, 900 Boylston St. Boston, MA 02115.  Please stop by booth #1130 and say hello to ICQ Consultants!

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An ISPE Event: Focused Trends from FDA: What are they focusing on during their inspection?

Shire will be hosting an upcoming live program on the FDA’s inspection trends and focuses featuring an ex-FDA inspector and an industry Quality representative.   The event will be held Thursday, September 21 from 4:30 P.M. to 9:00 P.M. at Shire’s Fortis Lecture Hall located at 200 Shire Way, Lexington, MA 02421.  The program will feature a facility tour, networking reception including refreshments and a live Q&A session at the end of presentation.  The tour portion of this event is open to ISPE Members ONLY. You can register for this event on the ISPE Boston Chapter Website.  Jolly Bhatia, Senior Director of Quality Assurance for DC73253LOGOAlnylam Pharmaceuticals and Mark Lookabaugh, Principal Consultant of PAREXEL Consulting will both be speaking.  Hurry and register by 9/14/17 for discounted prices!

 

 

SCHEDULE:

4:30 – 5:15 PM Members Only Tours
5:30 – 6:30 PM Registration and Networking Reception
6:30 – 8:30 PM Presentations

LOCATION:

Shire
Fortis Lecture Hall
200 Shire Way
Lexington, MA 02421

 

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“Magic Fields”, Microsoft Word Help

Recently, I have been helping ICQ with internal support tasks.  One such task involves the templates we will be using in the course of client project work, to standardize our communications.  Many of the templates have a field to populate the document number, and when I clicked on it to check the font properties, a box appeared around the placeholder number, and a tiny “Keyword” appeared in an even smaller grey box above it.   This field is tied to the same document number field in the footer, and when one of those fields is populated, the linked field follows suit.  I was intrigued.  As I studied the templates, I noticed other places where information was repeated, and I thought, “If we used more of these in our documents, the form becomes more user-friendly, AND the potential for inconsistencies is eliminated.”  Once I had administrative buy-in, I dug into the Word tutorials and learned how to implement the fields.  If you’re thinking “How can *I* add this to my document generation skill set?”, follow me!

Step 1: If you’re interested in customizing the names of the “magic” fields, you’ll need to add the Developer tab to the ribbon at the top.   File> Options> Customize Ribbon and make sure the Developer box is checked.word1

Step 2: Select your placeholder text.  Now, go to Insert> Quick Parts> Document Property and pick one of the field titles from the list.  If it doesn’t really describe the attribute, you can change the name later. (That’s why we did Step 1).word2

(Note: If you remove the content of the document property field, the name of the field takes its place.)

Step 3: Move to the other places in your document where you would like the information to auto-populate.  Highlight the text and repeat Step 2, choosing the SAME field name.

All fields with the same name will be connected, so editing the text within one will edit them all.

Step 4: Optional renaming of the fields

Here’s where that Developer tab comes in.  Click on this tab, then Properties.  The pop-up menu allows you to re-label your “magic” fields.

The one minor (ironic) inconvenience is that you will have to re-name each one individually.

One final troubleshooting tip.  If the Document Property menu item shows as light grey/disabled, chances are the file opened in “compatibility mode”.  Simply convert it, and the option should start working.

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By: Victoria Hayes, Senior Consultant
ICQ Consultants

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ICQ Quarterly Newsletter

Please click the link below to enjoy our latest Quarterly Newsletter.  Be sure to check out all the added links!

ICQ_2017-08_Newsletter

NE PDA Dinner Meeting

pdaeventPlease join us in supporting ICQ’s victoriavery own Victoria Hayes who will be the meeting host for the next New England PDA Dinner Meeting held on March 15th.  “Microbial Contamination and Effective Facility Decontamination in the GMP Setting” will be held March 15, 2017 beginning at 5:30 pm and running to 9:00 pm at the Marriott Burlington, One Burlington Rd., Burlington, MA 01803.  Dr. Ed Balkovic and Mark Czarneski  willpda-logo both be presenting on the topic.    We encourage everyone to attend and support Victoria.  ICQ is once again a Gold Sponsor for 2017 and will be sponsoring a  table at the PDA Dinner Meeting events.  Please feel free to stop in and say hello!

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