Quality Assurance Specialist

•Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence.
•Responsible for performing inspection and disposition of raw materials and components by:
•Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
•Obtaining Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.
•Reviewing and verifying all incoming documentation to confirm that materials meet defined testing specifications and quality standards.
•Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.
•Archiving finalized Master Specifications and associated release documentation in the document control room, maintaining accurate and organized records.
•Proactively assess potential risks and implement mitigation strategies, ensuring timely communication with relevant stakeholders.
•Complete assigned training and tasks within required timelines, represent the Quality function in cross-functional meetings, and provide feedback to the team as needed.
•Provide quality oversight and compliance guidance in accordance with company procedures and standards outlined in the SMPA Quality Management System.
•Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.
•Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.
•Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner.
•This role is an on-site position, scheduled Monday through Friday, primarily supporting GMP operations. The standard working hours are from 8:00 AM to 4:00 PM; however, flexibility may be required based on business needs.

Qualifications
•B.S. in chemistry, biological or pharmaceutical sciences, or related discipline
•At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
•Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
•Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
•Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.
•Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs.
•Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.
•Working experience in KNEAT, SlingShot, SAP, Blue Mountain RAM and VEEVA is preferred.

Pay ranges between $34-38/hr based on experience