Quality Assurance Lead in Waltham, MA

Job Description:

• Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
• Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
• Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.
• Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
• Write, revise and perform QA review and approval on SOPs, forms, WI, and other document types.
• Provides iShift support for GMID and BOM approval.
• Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
• Assume additional responsibilities as assigned.

Competencies/ Requirements for position

Qualifications/ Education & work experience

• Bachelor's and/or 8+ years of relevant experience
• Minimum 5 years of experience in Quality
• Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
• Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
• Must have excellent attention to detail, project and time management skills, and the ability to
  • manage multiple priorities with aggressive timelines.
  • Preferred experience with outsourced manufacturing and testing operations
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.

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