Quality Assurance Specialist
Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Philadelphia, PA.
- Independently create and reviews GMP documentation including SOPs, Annual Product Quality Reviews, Risk assessments, Supply chain map and reports as required.
- Lead/support assessment of data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs.
- Lead/support process lifecycle and analytical lifecycle management initiatives.
- Lead/facilitates stakeholders meeting and track actions to completion on QA and compliance topics / issues relating to company manufacturing and product supply including Stability review boards and Product Specification Committees.
- Provide support for deviation, investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
- Lead/partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc.
- Proactively contribute to management of product quality risks ensuring they are proactively mitigated, actioned, and escalated to senior management.
- Independently performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk.
- Actively contributes to continuous improvement activities.
Skills and Requirements:
- Demonstrated ability in decision making, problem solving and project management.
- Excellent accuracy and attention to detail.
- Good knowledge of relevant computer packages e.g. Excel, Word, Veeva Vault, Trackwise.
- Planning and organizing skills are required to plan, execute and track GMP commitments and to adjust to changing priorities. Highly nimble.
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
- Excellent understanding of cGMP requirements for pharmaceutical manufacturing and Quality Control.
- Knowledge of manufacturing and analytical processes for pharmaceutical products.
- Knowledge of quality systems with a strong business and technical acumen would be an advantage
- Understanding of quality risk management principles.
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.