Quality Assurance Manager
2 days ago
Quality Assurance Manager
About Us:We are PCI Pharma Services, a leading global contract development and manufacturing organization (CDMO) dedicated to the healthcare industry. Our mission is to deliver life-changing therapies by bridging the gap between pharmaceutical companies and their patients.
Job Description:We are seeking an experienced Quality Assurance Manager to join our team. This role will be responsible for ensuring that all quality-related tasks associated with customer accounts are completed to the desired standard and on time.
- Main Responsibilities:
- Ensuring receiving reports, batch records, and QP release requests are completed on time and documents shared with customers as applicable.
- Processing customer-related information through applicable workstreams once data is verified, identifying any issues during customer receipt, batch record review, or QP release, and ensuring appropriate resolution and tracking/trending.
- Assisting with investigations of customer-related quality issues/deviations/issues and drafting investigation reports on time to customers.
- Disposition of events and non-conformances as applicable.
- Completing customer-specific action items from audits, investigations (e.g., CAPAs), and reporting/customer metrics/key performance indicators (KPIs).
- Presenting quality information to customers during calls or Business Review Meetings (BRMs) and attending conference calls and customer meetings.
- Providing subject matter expert input to investigations/complaints and other quality-related information.
- Generating and presenting quality-related metrics and KPIs for team performance internally and externally.
- Assisting with addressing and documenting quality events with Production, Project Management, and Quality teams.
- Mentoring QA Team members and other departmental personnel.
- Knowledge of and adherence to all relevant PCI procedures and GMP rules/guidelines.
- Developing, updating, and implementing procedural changes throughout Quality Management Systems across sites.
- Standardizing documentation to ensure PCI's Standard for Quality is achieved throughout our customer base.
To be successful in this role, you will need:
- Education: A University degree in a scientific or health-based field.
- Experience: Ideally, experience in the pharmaceutical industry or related field with good knowledge of European GMP/GDP legislation and guidelines (or ISO quality management system standards).
- Skills: Proficiency with MS Office Suite programs and ideally experience in hosting/participating in audits.
We offer a competitive salary of $90,000 - $110,000 per year, depending on experience, plus benefits including medical, dental, and vision insurance, 401(k) plan, and paid time off.
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