GMP QA Specialist, Cell & Gene Therapy

Actalent; Winston-Salem (NC); On-site; USD 47,000 - 52,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO / Vacation

Job summary

Actalent in Winston-Salem, NC, seeks a Quality Assurance Specialist to support GMP batch and material release activities. You will review documentation, track data in GMP databases, and escalate issues to senior QA staff while supporting internal and customer audits.

The role requires attention to detail, strong communication, and experience in a regulated pharmaceutical or biotech setting. This onsite position offers a contract-to-hire path with competitive hourly pay.

Qualifications

• Associates Degree with relevant GMP-regulated experience, or a Bachelors in Life Sciences, Chemistry, Pharmacy or related field plus 2 years GMP experience.
• Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations.
• Experience with batch record review and material release documentation in a regulated environment.
• Familiarity with deviation management and CAPA processes, with experience participating in or supporting investigations preferred.
• Basic familiarity with FDA, EU, and/or ISO regulatory frameworks preferred.
• Hands-on experience in Quality Assurance within pharmaceutical or biotech manufacturing, including inspection and audit support.
• Ability to perform detailed document control activities, including accurate data entry and maintenance of GMP records.
• Strong analytical and problem-solving skills to support investigation and analysis of deviations and non-conformances.
• Effective written and verbal communication skills for interacting with cross-functional teams and senior management.
• Strong attention to detail and ability to follow established SOPs, procedures, and quality standards.

Responsibilities

• Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases in accordance with established procedures.
• Prepare and conduct initial reviews of batch and material release documentation, ensuring conformance with applicable SOPs, specifications, and acceptance criteria.
• Evaluate manufacturing, filling, labeling records, and analytical data for regulatory compliance and company requirements, escalating discrepancies to senior QA staff.
• Report key quality metrics and performance indicators using templates and reporting tools.
• Perform hands-on monitoring of production and non-production activities, identify non-compliance, and report issues to Quality Management.
• Support confirmation that finished products conform to internal standards and cGxP regulations and government requirements.
• Participate in internal and external audits, including customer and regulatory audits.
• Assist in investigating deviations under guidance of senior QA staff, contribute to root cause identification, and propose corrective actions.

Skills

GMP

cGxP

Batch review

Deviation management

Documentation control

Audits participation

Regulatory awareness

Communication

Attention to detail

Education

Associates Degree or Bachelor's Degree in Life Sciences or related field + 2 years GMP experience

Tools

GMP databases

Job description

Actalent in Winston-Salem, NC, seeks a Quality Assurance Specialist to support GMP batch and material release activities. You will review documentation, track data in GMP databases, and escalate issues to senior QA staff while supporting internal and customer audits.

The role requires attention to detail, strong communication, and experience in a regulated pharmaceutical or biotech setting. This onsite position offers a contract-to-hire path with competitive hourly pay.