Senior Quality Assurance Specialist

Join to apply for the Senior Quality Assurance Specialist role 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.

• Assure compliance to all regulatory requirements, current Good Manufacturing Practices, and company policies, standard operating procedures and work instructions.
• 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.
• Ensure cGMP compliance of assigned manufacturing operations/areas.
• Complete QMS items as assigned.
• Be responsible for the conditional/final release of materials.
• Host customer and internal audits, as needed.
• Conduct internal and external audits, as needed.
• Participate in inspections by regulatory authorities.
• Write and review annual product reviews/product quality reviews.
• Write and review product validation/qualification/assessments documents.
• Write and review equipment qualifications/assessments documents.
• Write and review computerized systems validations/assessments documents.
• Review, evaluate and approve minor equipment changes.
• Conduct GMP inspections.
• Conduct environmental monitoring.
• Review and approve CMC sections of DMFs as appropriate.
• Maintain QA databases for products/equipment as appropriate.
• Adhere to personal moral, ethical, legal and behavioral conduct in compliance with the Siegfried Code of Conduct.
• Adhere to all applicable SHE and cGMP regulations (e.g., ICH Q7, FDA, 21 CFR 210 and 211, etc.).

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

• 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.

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.

Paid Time Off, Health Insurance, Retirement Planning

Mid‑Senior level

Full‑time

Quality Assurance

Pharmaceutical Manufacturing and Chemical Manufacturing

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof.

This unique combination of know‑how and experience makes us the most trusted partner in the pharmaceutical industry.