Sr. Quality Assurance Specialist

Exciting Challenges And Opportunities At Siegfried

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:

The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.

Your Profile:

Essential duties, responsibilities and accountabilities:

• Review, approve and track executed production records.
• Review and approve production and QC investigations.
• Review lab sample results and manufacturing records related to qualification/validation activities.
• Conduct, write, and review quality related investigations as appropriate.
• Review and approve Master Production Records.
• Responsible for cGMP compliance of assigned manufacturing operations/areas.
• Complete QMS items as assigned.
• Is responsible for the conditional/final release of materials.
• Hosts customer and internal audits, as needed
• Conduct internal and external audits, as needed
• Participates in inspections by regulatory authorities
• Writes and reviews Annual Product Reviews/Product Quality Reviews
• Writes and reviews Product Validation/Qualification/Assessments documents.
• Writes and reviews Equipment Qualifications/Assessments documents.
• Writes and reviews Computerized Systems Validations/Assessments documents.
• Reviews, evaluates and approves minor equipment changes.
• Conducts GMP inspections.
• Conducts environmental monitoring.
• Reviews and approves CMC sections of DMFs as appropriate.
• 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 e.g. ICH Q7, FDA, 21 CFR 210 and 211, etc.

Education And Experience:

• A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in QA in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience.
• Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable.

Your Benefits:

Other requirements:

• Must have excellent communication skills.
• Must be conscientious and detail oriented.
• Must have excellent computer skills (MS Office 365).
• 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.
• Must be able to adhere to deadlines.
• The salary for this role is anticipated to be between $82,000 and $110,000.

Siegfried USA, LLC will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job. Please speak with HR should you require an accommodation or have any questions.