The position will perform QA work responsibilities in support of manufacturing and facility operations, including quality systems and projects. Functions include proactive support of change control assessments, documentation reviews, discrepancy identification and resolution on the floor.
- 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 and author annual product reviews.
- Participates in the review and revision of Compliance-related controlled documents.
- Extensive knowledge of US Drug Product cGMP requirements and associated guidelines
- Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
- Ability to increase others knowledge of US and European GMP regulations and guidance
- 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
- Bachelor’s degree in a scientific discipline or equivalent required
- Minimum of 5-8 years’ experience in a Quality Assurance role in the pharmaceutical industry preferred
- CQA preferred
Phone: 860-278-5840 ext 245