QA Specialist

QA Specialist

101 Southcenter Court, Morrisville, NC

5 days onsite

• Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floo 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.

If interested share the resume to aparna.yerravalli .com