Job Description

Job Title: QC Peer Reviewer Specialist I
Requisition ID:153702BR

When you2019re part of the team at Thermo Fisher Scientific, you2019ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you2019ll be supported in achieving your career goals.

Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need. We work in close collaboration with each client's team to deliver successful programs. Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases. The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients. 200BThis exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market. 200B

Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we'll enable breakthroughs in science that improve patients' lives and bring hope for a healthier world!

How will you make an impact as a peer reviewer?

The QC Peer Reviewer will work with a team of Scientists and analysts to technically review data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots. The Peer Reviewer will communicate status updates on these activities to QC Management, Project Management, and QA to ensure that these activities meet project and production objectives on time.

The role will also support deviation investigations (OOS/OOT, etc) that occur within the QC laboratory. Occasionally create, revise, edit and prepare QC documents required for the functioning of the analytical GMP QC laboratory. The QC Peer Reviewer will work cohesively with QC Management to ensure consistent delivery and execution of high-quality assay records and laboratory-related documentation.

What will you do as a peer reviewer?

* Independently perform technical review of data, test records and reports generated during testing of GMP clinical lots, cell and viral banks as well as Process Development lots.
* Occasionally assist with creating and revising QC Standard Operating Procedures, Test Records, Stability and Assay Qualification Protocols and Reports.
* Support deviation investigations (OOS/OOT, etc) that occur within the QC laboratory
* As needed, review results and deviations/ investigations from CTLs as well as our in-house microbiology group.
* Other duties as assigned by supervisor.

This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.

How will you get here?

* A Bachelor2019s degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization required.
* One to three years of appropriate experience preferred. College coursework may substitute at an equivalent rate for the required experience.
* Experience with technical writing or other document review preferred.
* Laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are required for this position. QA or QC experience in analytical testing and development is strongly recommended.

Knowledge, Skills, Abilities

* Proficiency with Microsoft office programs such as Word, Excel, and PowerPoint.
* Excellent technical writing and oral communication skills are required.
* Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Excellent organizational skills.
* Ability to communicate/work in a high pressure/high paced environment
* Ability to multi-task and function effectively as a member of a team

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission2014enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.