Job Information
Alkermes, Inc. Sr QA Associate I/II - 13153 in Wilmington, Ohio
Overview
Applicants invited to apply for Senior QA Associate I/II role in Quality assurance department. Reporting in the first instance to the QA Manager of Sterile Operations, the successful candidate will have the key responsibilities as outlined below.
Responsibilities
- Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations.
- Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents
- Identifies compliance risks and develops sound rationale as basis for audit observations.
- Supports the coordination activities and assists with interactions during regulatory agency inspections
- Perform internal audits.
- Participates in the review and revision of Compliance-related controlled documents
*Skills / Qualifications *
- 6-8 years' experience in the pharmaceutical quality function for a Sr. QA Associate I
- 8+ years' experience in the pharmaceutical quality function for a Sr. QA Associate II
- Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
- Experience in quality systems for drug product manufacturing and quality control operations
- Experience in Pharmaceutical aseptic operations
- Project management experience including scheduling, tracking and auditing
- Technical expertise and understanding of cGMP sterile filling manufacturing processes
- Strong problem analysis (root cause analysis, risk assessment, and CAPA development) skills are preferred
- Experience in document and change control review/ approval and auditing
- Familiarity with Validation documentation, qualification of facilities, utilities, equipment and processes
- Ability to effectively plan, organize and prioritize work
Education
- Bachelor's degree in a scientific discipline or related field
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