Quality Control Manager - Permanent Job

Company Name:
Salary period: Annual
Quality Control Manager needed for a direct hire opportunity with Yoh's client located in Plainsboro, NJ
The Big Picture:
- The QC Senior Scientist will be responsible for QC lab operation management, QC method/data management and provides supports to QC head to meet project timelines in a fast-paced team environment.
What You'll Be Doing:
- Effectively interact with BMC and CRO for raw material release.
- Review and approve analytical test method/specification/results of raw material tested either in-house or by CRO in accordance with cGMP regulations.
- Ensure CROs are following analytical procedures and specifications.
- Oversee sample submission tracking and document tracking used to the Quality Control laboratory specifying tests required for lot release, stability and cleaning validation.
- Review of test results of drug substance, finished products, stability and microbiology samples using in-house and EP/USP methods for lot release and stability evaluation.
- Update and track stability testing database as samples are tested and reviewed.
- Coordinate the change control and planned deviations requests applicable to stability, lot release and raw material sample.
- Review SOP's, analytical procedures and product specifications to ensure that all standards are met in accordance with cGMP and company guidelines/FDA and EMA regulations.
- Communicate review findings to QA/QP, discuss various approaches recommend solutions to audit findings and suggest appropriate CAPAs
- Maintain and control laboratory documentation within QC.
- Provide training to juror scientist. Responsible for QC lab safety.
What You Need to Bring to the Table:
- BS/MS/PhD in Biochemistry/Biotechnology/Analytical Chemistry or related subject area.
- At a minimum five to six (5 - 6) years of relevant industry experience with focus on analytical quality control and analysis testing support for raw material release, drug substance/drug product lot release and stability for Biological Manufacture.
Bonus Points! Otherwise Known As Preferred Qualifications:
- Large Molecule and Protein Experience
What's In It For You?
- This is your chance to shine while supporting our client's dynamic Product Marketing, drug development and Research teams.
Get Hired, Apply Now!
Recruiter: Sidra Chaudhry
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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