Sr. Quality Assurance Specialist

"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 s , approve and track s executed production records. Review s and approve s production and QC investigations. Review s lab sample results and manufacturing records relat ed to qualification/validation activities. Conduct s , write, and review s quality related investigations as appropriate . Review s and approve s Master Production Records. Responsible for cGMP compliance of assigned manufacturing operations / areas. Complete s QMS items as assigned. Is responsible for the c onditional / 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 Write s and review s Product Validation / Qualification / Assessments documents . Write s and review s Equipment Qualifications / Assessments documents. Write s and review s Computerized Systems Validations / Assessments documents. Review s , evaluates and approve s minor equipment changes . Conduct s GMP inspections . Conducts e nvironmental monitoring. Review s and approve s CMC sections of DMFs as appropriate . Maintain s 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. Adhere s to all applicable SHE and c GMP 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 y ears of experience in QA in a pharmaceutical manu facturing 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 b