Sr. Quality Assurance Specialist

Your Role

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 and QC investigations.
• Reviews lab sample results and manufacturing records related to qualification/validation activities.
• Covers, write, and reviews quality related investigations as appropriate.
• Reviews and approves Master Production Records.
• Responsible for cGMP compliance of assigned manufacturing operations / areas.
• Completes 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.

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.

Benefits

• The salary for this role is anticipated to be between $82,000 and $110,000

Pay

The salary for this role is anticipated to be between $82,000 and $110,000

Schedule

Full time