Quality Assurance (Specialist )

Overview

The QA Specialist is responsible for providing Quality and Compliance oversight for the manufacturing of commercial and investigational products. This includes active shop-floor presence, raw material inspection, batch record review, and ensuring adherence to GMP requirements and internal quality standards.

Responsibilities

• Provide Quality and Compliance oversight for GMP manufacturing operations through regular shop-floor interaction.
• Perform inspection and disposition of raw materials and components.
• Support incoming material release in the ERP system, ensuring compliance with regulations and internal procedures.
• Obtain and verify CoAs, CoCs, and other required vendor documentation per Master Specifications.
• Review incoming documentation to confirm materials meet defined testing specifications and quality standards.
• Coordinate with cross-functional teams regarding disposition of released or rejected materials, ensuring timely movement to proper storage or quarantine.
• Archive finalized Master Specifications and release documentation in the Document Control Room, maintaining organized and accurate records.
• Identify potential risks and implement mitigation strategies with timely communication to stakeholders.
• Complete assigned training and tasks within required timelines and represent Quality in cross-functional meetings.
• Provide quality oversight and guidance according to company procedures and the SMPA Quality Management System.
• Conduct detailed reviews of logbooks and work orders across Manufacturing, Engineering, Quality, and Warehouse departments.
• Review and approve completed Manufacturing Batch Records, ensuring accuracy and compliance with company policies.
• Take on additional duties assigned by the manager in a professional and timely manner.

Qualifications

• B.S. in Chemistry, Biological Sciences, Pharmaceutical Sciences, or a related discipline.
• Minimum 3 years of experience in the biotech or pharmaceutical industry (R&D or commercial environments).
• Experience in a cGMP manufacturing environment with strong knowledge of FDA requirements and guidance.
• Hands-on experience with manufacturing operations, batch record review, and/or analytical processes.
• Strong integrity, ownership mentality, and commitment to excellence.
• Ability to work flexibly, adapt to changing business needs, and support the team with additional tasks.
• Strong organizational skills and ability to manage multiple projects with tight timelines and minimal oversight.
• Preferred software experience: KNEAT, SlingShot, SAP, Blue Mountain RAM, VEEVA.

Job Type: Contract

Pay: $36.00 - $38.00 per hour

Work Location: In person

Salary : $36 - $38