Quality Control Manager
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location: Waltham, Massachusetts
job type: Contract
salary: $69.18 - 81.39 per hour
work hours: 9 to 5
The Manager Quality Control is responsible for the day-to-day oversight of analytical testing at contract laboratories and contract manufacturing facilities for testing of development pharmaceutical products and drug substances in support of small molecule and/or immuno-oncology programs. The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of analytical test reports or certificates. This includes assisting with QC checks and preparation of regulatory filings (IND, BLA and NDA), and manage projects associated with drug substance and products.
- Assist in the management of drug substance and drug product analytical testing at contract laboratories
- Assist in the management of stability activities including data review and trend evaluation.
- Investigate and resolve analytical test failures (OOS and atypical results)
- Monitor contract laboratory activities to ensure compliance and timeliness of certificates of approval and reports
- Review QC raw data and assist in batch release.
- Assemble data packages in support of specification and method changes associated with TESARO products
- Represent QC in cross-functional teams with internal and external customers
- Assist in the preparation of the analytical sections of regulatory filings (Supplements, and Annual Reports)
- Review and approve various quality documents (internal and external) associated with TESARO products
- Provide analytical support for manufacturing investigations as required
- Participate in vendor and internal audits as needed
- Contribute to company quality systems
- Maintain current knowledge of all relevant USP/NF and EP requirements and FDA/EU guidances.
- Other duties as assigned.
Education & Qualifications:
- BS in a scientific area
- 5+ years' experience in the pharmaceutical/bio-pharm manufacturing industry with at least 1 of those years at the QC manager level
- Knowledge of analytical testing concepts and current cGMPs including laboratory controls and good documentation practices
- Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts
- Experience building relationships and working with CMOs
- Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
- Excellent written and oral communication skills.
- Competency in MS Office Products and Adobe Acrobat
- Independently motivated and detail oriented with good problem-solving ability.
- Ability to work a flexible work schedule to accommodate program priorities and international activities as needed
skills: ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.