Sr. Quality Assurance Specialist

Position Overview The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions. Key Responsibilities Reviews, approves, and tracks executed production records. Reviews and approves production and QC investigations. Reviews lab sample results and manufacturing records related to qualification/validation activities. Conducts, writes, 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. Conducts 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 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.). Qualifications 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. Required Skills Excellent communication skills. Conscientious and detail oriented. Excellent computer skills (MS Office 365). Team player. Self-manage daily work and set priorities. Manage projects and prioritize appropriately. Adhere to deadlines. Compensation Salary range: $82,000 - $110,000. Accommodations Siegfried USA, LLC will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his or her job. Please speak with HR should you require an accommodation or have any questions. #J-18808-Ljbffr