QC ManagerApply Now
Location: Woburn, Massachusetts 01801
Employment Type: Contract
Job Description
Contract Length: 6 months; 100% on-site position
Job Summary: The Quality Control Manager will ensure the QC laboratories are set up to support production and the stability program while ensuring that data results from the lab are accurate and precise.
Responsibilities:
Requirements:
Job Summary: The Quality Control Manager will ensure the QC laboratories are set up to support production and the stability program while ensuring that data results from the lab are accurate and precise.
Responsibilities:
- Provide leadership in the QC organization to ensure compliance, drive improvements and achieve schedule adherence.
- Work with cross-functional teams to align testing schedules to meet production needs
- Manage applicable deviations, CAPAs and investigations
- Manage Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
Requirements:
- Knowledge of CFR 210, 211, USP, and FDA/ICH guidance
- Understand procedures and policies, Good Documentation Practices and Good Laboratory Practices
- Strong organizational skills and project management skills
- Excellent written and verbal communication skills with high attention to detail
- Demonstrates ability to exercise good judgment and make decisions quickly
- Bachelor of Science degree in Life Sciences, Chemistry or Biology
- Minimum 5-7 years related experience in a CGMP QC lab of pharmaceutical industry
Contact
Christian Griffith
Principal Recruiter
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