Quality Assurance Specialist

Piper Companies is currently looking for an experienced Quality Assurance Specialist in Lititz, PA to join a leading pharmaceutical company for a long-term contract position.

Responsibilities for Quality Assurance Specialist include:

• Manage and track quality investigations and CAPAs to ensure they are assigned, completed on time, and properly documented.
• Monitor investigation and CAPA trends, generate metrics, and support CAPA review meetings.
• Follow up with teams on open investigations and CAPAs to ensure deadlines are met.
• Assist with customer complaint investigations and provide summaries of findings.
• Keep QA leadership informed of investigation status, risks, overdue items, and key quality initiatives.
• Analyze investigation and CAPA data to identify recurring issues, support root cause analysis, and maintain quality reporting metrics.
• Partner with manufacturing, operations, and quality teams to drive timely investigation and CAPA closure.

Qualifications for the Quality Assurance Specialist include:

Experience:

• Basic knowledge (Plant QA experience preferred) in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements Production

Knowledge, Skills and Abilities:

• Ability to collaborate with internal/external partners to enhance relationships and interactions, including interaction with management to inform, inspire change, and provide direct feedback.
• Proven track record to accomplish work goals, with a modest amount of daily direction and oversight.
• Ability to be on site daily
• Quality Process and Systems Experience, especially with SOPs, MWI, Change Controls, Non-Conformance Investigation Documentation
• Problem Solving

Compensation for the Quality Assurance Specialist include:

• Salary based on experience
• Comprehensive benefits package

Keywords

Pharmaceutical, Quality Assurance, QA, Clinical Supplies, Vaccine, MS Office, BS, Science, comprehensive benefits package, Health, Vision, Dental.

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