Quality Assurance Specialist

Accentuate Staffing is partnering with a well-established biopharmaceutical company who is hiring for Quality Assurance Specialists to join their team. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate has hands-on quality assurance experience, strong knowledge of quality management principles, and the ability to collaborate effectively across scientific and operational teams.

Responsibilities:

1. Review and approve client materials, validation documentation, facility forms, and completed inventories in alignment with SOPs, client specifications, and regulatory requirements.
2. Oversee the release, transfer, shipment, and destruction of biological materials, ensuring accurate labeling and documentation.
3. Participate in internal audits, generate client reports, and support special projects to maintain compliance and continuous improvement.
4. Ensure strict adherence to safety regulations when handling potentially infectious or biohazardous materials, following OSHA and HIPAA guidelines.
5. Collaborate effectively with Operations and Management teams to maintain high-quality standards and timely workflows.
6. Utilize LIMS and other quality management tools to track, document, and communicate QA outcomes efficiently.

Requirements:

1. Bachelor’s or associate degree in life sciences, healthcare, quality management, or a related field—or equivalent combination of education and experience.
2. One year, or more, of biorepository or laboratory experience, with a minimum of 1–2 years in a QA or quality management role preferred.
3. Strong understanding of quality management systems (QMS), GMP regulations, and quality assurance principles.
4. Proficiency in LIMS and other computer systems; ability to prepare quality and statistical reports is highly desirable.
5. Exceptional organizational, time management, and communication skills, with the ability to maintain confidentiality.
6. Demonstrated ability to collaborate, lead by example, and support operational excellence in a fast-paced laboratory or pharmaceutical environment.

• Facilitate preparation of Authorization memos and maintain as inspectionready CAPA System
• Maintain all audit records in accordance with Record Retention Schedule SOP System Maintain QMS system
• Assist with annual budget preparation TMSWeb QMS Computerized System
• Assist with the scheduling of the Audits, both Vendor and Inhouse
• Developed, work with technical teams to optimize the user experience and train / orient others
• Prepare and maintain Operating Procedures Location
• Perform batch testing, raw material testing, and batch adjustment calculations for all materials
• Log and classify work orders
• Notify authors, issue draft documents for revision, track to completion
• Evaluate results of tests conducted and approve that meet all batch acceptance-testing specifications
• Manage filing of the completed and closed CAPAs in the system
• Perform inventory of released aircraft log books
• Verify the accuracy of data and logic used to compile reports
• Provide relevant notifications to functional areas regarding CAPA implementations and closure
• Prepare work orders for FAA inspections
• Assign documents numbers and DCR be to departments for document revision
• Support Complaint Handling Process And Processes Complaints Mdr & Vigilance
• Support Internal, External, And Third-party Audits
• Identifying potential illogical conditions based on data and procedures
• Collate and prepare documents for QA Authorization