Quality Assurance Specialist

Title: QA Specialist

Location: Morrisville, NC

Duration: 3 Months

SUPPLIERS: THIS ROLE IS ONSITE MONDAY-FRIDAY, NO SHIFT WORK.

Description:

· 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.

QA 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.