What are the responsibilities and job description for the Quality Assurance Specialist position 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:
SUMMARY:
The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
EDUCATION AND EXPERIENCE:
Siegfried USA 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.
Your Benefits:
Paid Time Off, Health Insurance, Retirement Planning
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.
Your Role:
SUMMARY:
The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
- 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.
EDUCATION AND EXPERIENCE:
- 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.
Siegfried USA 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.
Your Benefits:
Paid Time Off, Health Insurance, Retirement Planning
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.
