Sr. Quality Assurance Specialist
| Company | Pfizer |
|---|---|
| Location | Sanford, NC, USA |
| Salary | $80300 – $133900 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, Associate’s |
| Experience Level | Senior |
Requirements
- BA/BS degree in Biology, Chemistry, Micro and Bioanalytical with 2+ years of experience OR MBA/MS degree in Biology, Chemistry, Micro and Bioanalytical with any years of relevant experience OR Associate’s degree with 6+ years of experience OR High school diploma (or equivalent) with 8+ years of experience.
- Experience in Quality Control Laboratory (e.g., transfer, equipment qualification, analytical testing, stability, etc.) cGMP’s Laboratory environment (Pharmaceutical industry)
- Familiarized and experience in Pharmacopeia requirements (e.g., USP, JP, EMEA amongst others)
- Experience or familiarized with Data Integrity requirements
- Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
- Strong critical thinking skills, problem solving and analytical skills
- Attention to detail and ability to work independently
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Provide excellent communication writing and analytical skills
Responsibilities
- Work to develop and implement quality assurance procedures and guidelines to support the Quality Control team’s testing and evaluation efforts.
- Perform QA technical review for assigned areas such as Validation documents, Method transfer Protocol amongst others.
- Provide final QA approval on more complex change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the business unit.
- May also review and approve Deviation, complaints investigations, Laboratory investigations (OOS/OOT/OOE), and other Quality Events/Lab Events, Electronic build Master Batch, or any electronic record when needed, and all associated with compendial changes.
- Drives compliance, efficiency, and process improvement projects.
- Capable to make complex quality decisions in real time according to regulations and procedures.
- Interfaces with internal partners to resolve technical issues.
- Perform other duties as assigned and take ownership to support the implementation of activities needed for the start-up.
- Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
- Approve investigations and change control activities to maintain compliance with configuration management policies.
- Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
- Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
- Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Preferred Qualifications
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
- Proven ability work in a team environment through conflict resolution and negotiation