Quality Assurance Specialist
About The Position
Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact. Your Role: SUMMARY: The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.
Requirements
- A BA/BS degree in microbiology, biology, or chemistry, or 2-3 years of experience in batch record review in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
- Thorough knowledge of cGMP is required.
- Must have excellent communication skills.
- Must be conscientious and detail-oriented.
- Must have excellent computer skills (MS Office, WinLIMS, SAP).
- Must be a team player.
- Must be able to self-manage daily work and set priorities.
- Must be able to manage projects and prioritize appropriately.
Responsibilities
- Reviews, approve and tracks executed production records.
- Reviews and approves production investigations.
- Reviews lab sample results and manufacturing records relative to qualification/validation activities.
- Reviews and approves Master Production Records.
- Responsible for cGMP compliance of assigned manufacturing operations / areas.
- Completes pre-campaign action items as assigned.
- Is responsible for the conditional / final release of materials.
- Reviews finished product labels.
- Reviews and approves COAs.
- Prepares and reviews product trees.
- Writes Process Qualification Documents
- Assists with GMP inspections
- Conducts environmental monitoring
- Maintains QA databases for products / equipment as appropriate.
- Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Siegfried Code of Conduct.
- Adheres to all applicable SHE and CGMP regulations.
Benefits
- Paid Time Off
- Health Insurance
- Retirement Planning
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
