Quality Assurance Specialist - QA on the Floor

Quality Assurance Specialist - Biopharma/Lab

Chapel Hill, NC

(On-site/NO C2C/USC or Green Card Holders)

Direct Hire!

$68,000-$74,000 a year

About our Clients: They support clinical trials requiring human cellular therapy products at a Cancer Center. Cellular therapy products are generated and expanded in this facility for patients receiving adoptive cell therapy for the treatment of cancer. The facility includes core staff who are highly experienced in the manufacture of a wide variety of cellular therapy products.

Job Summary: The Quality Assurance Specialist - QA on the Floor plays a critical role in ensuring the quality and compliance of manufacturing operations within the company. This position primarily focuses on batch record issuance, batch review, occurrence investigation, and resource support for policies and procedures. The ideal candidate will possess strong technical writing skills, attention to detail, and a commitment to continuous improvement.

Key Responsibilities

Batch Record Issuance:Assist in the creation of batch records and necessary forms to support manufacturing processes. Batch Review:Conduct real-time initial reviews of batch records and provide feedback on manufacturing operations. Coordinate with QC -Equipment and QC – EM Roles to address manufacturing needs. Occurrence Investigation:Initiate and investigate occurrences that arise during manufacturing processes. Error Tracking and Feedback:Track manufacturing errors and provide feedback for metric analysis. Technical Writing and Resource Support:Serve as a technical writer and resource for policies, Standard Operating Procedures (SOPs), forms, worksheets, and job aids supporting quality and manufacturing operations. Assist manufacturing in identifying necessary policies, SOPs, and other required documents. Training Coordination:Ensure manufacturing employees receive required training to complete operations effectively. Implement and reinforce best practices in manufacturing operations in collaboration with production staff. Project Support:Act as a liaison for manufacturing to support projects as needed. Quality and EHS Compliance:Maintain annual competencies in required quality functions and stay up-to-date with required Environmental Health and Safety (EHS) LMS modules. Assist in training other QA/QC members in ACT Quality Systems. Assist in the maintenance of quality electronic systems. Continuing Education:Participate in 10 hours of continuing education annually in cellular therapy or quality topics.

Qualifications

Experience with MasterControl is beneficial. Strong understanding of quality assurance principles and manufacturing processes. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and prioritize tasks accordingly. Detail-oriented with strong analytical skills. Bachelor's degree in a related field or equivalent work experience.

Note: Responsibilities may be modified or added as needed, and discussions will be held with the Assistant Director of QA/QC and/or Associate Director of Quality and Facility Director. This job description is subject to change based on the needs of the company and industry standards.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity.

We look forward to speaking with you!