QA Specialist I: GMP Compliance & Batch Release

Actalent; Winston-Salem (NC); Sur place; USD 36 000 - 44 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision

Critical Illness & Insurance

401(k) Plan

Pre-tax & Roth

Life Insurance

Disability Insurance

Health Spending Account (HSA)

Transit Benefits

EAP

PTO & Leave

Résumé du poste

Actalent is seeking a Quality Assurance Specialist I to support Quality Operations in a fast-paced pharmaceutical environment. You will contribute to material and batch release activities, maintain compliant documentation, and assist with deviation and CAPA processes.

The role requires a foundational understanding of cGMP, strong attention to detail, and the ability to work under moderate supervision. This is an onsite position based in Winston-Salem, NC, with a pay range of $26.00–$32.00 per

Qualifications

• Bachelor's degree in life sciences, engineering, quality, or a related field; or an associate degree with at least two years of relevant experience in a regulated environment.
• Foundational understanding of cGMP requirements, controlled documentation, and data integrity principles.
• Ability to follow detailed procedures, recognize documentation errors, and escalation concerns appropriately.
• Strong attention to detail, organization, and written and verbal communication skills.
• Ability to manage routine priorities, meet deadlines, and work effectively with guidance.
• Proficiency with Microsoft Word and Excel.
• Exposure to electronic quality or document management systems preferred.
• Experience in cell or gene therapy and manufacturing quality.
• Audit preparation, investigation, and analysis capabilities.

Responsabilités

• Execute routine manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.
• Review documentation for completeness, legibility, traceability, required signatures, calculations, and adherence to data integrity expectations.
• Identify documentation discrepancies, communicate findings, and escalation potential compliance or release-impacting issues.
• Compile batch disposition documentation and confirm required records are available for review.
• Enter and maintain accurate batch review status, deficiencies, and follow-up actions in approved GMP systems and trackers.
• Follow-up on missing information, corrections, and documentation responses with Manufacturing, Quality Control, and Supply Chain.
• Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.
• Perform routine production-area observations and promptly report potential cGMP concerns.
• Complete required training, maintain current knowledge of assigned procedures, and participate in continuous improvement activities.
• Perform other quality-related duties as assigned.

Connaissances

Foundational cGMP & data integrity

Follow detailed procedures

Attention to detail & communication

MS Word & Excel proficiency

Formation

Bachelor's degree in life sciences or related field; or associate degree with 2+ years regulated experience

Outils

Electronic quality/document management systems

Description du poste

Actalent is seeking a Quality Assurance Specialist I to support Quality Operations in a fast-paced pharmaceutical environment. You will contribute to material and batch release activities, maintain compliant documentation, and assist with deviation and CAPA processes.

The role requires a foundational understanding of cGMP, strong attention to detail, and the ability to work under moderate supervision. This is an onsite position based in Winston-Salem, NC, with a pay range of $26.00–$32.00 per