Batch Release Specialist

Job Title: Quality Assurance SpecialistJob Description

The Quality Assurance Specialist provides critical support to Quality Operations, with a primary focus on material and batch release activities in a fast-paced pharmaceutical and cell therapy environment. Working within established Good Manufacturing Practices (GMP) and current Good Practices (cGxP), this role helps maintain regulatory compliance by supporting documentation, compliance monitoring, and quality system activities under moderate supervision. The successful candidate applies developing professional knowledge, strong attention to detail, and clear communication skills to ensure that products and processes meet internal standards and external regulatory requirements.

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 completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and internal requirements, escalating discrepancies to senior QA staff as needed.
• Report key quality metrics and performance indicators using established templates and reporting tools.
• Perform hands-on monitoring of production and non-production activities, identifying and promptly reporting observed non-compliance to Quality Management.
• Support confirmation that finished products conform to company and government standards and meet applicable cGxP regulations.
• Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management.
• Assist in investigating deviations under the guidance of senior QA staff, contributing to root cause identification and proposing corrective actions for review and approval.
• Identify compliance risks and effectively communicate observations to senior management, supporting the implementation of assigned action plans to mitigate risks.
• Promptly escalate critical quality issues to senior management, providing relevant documentation and context.
• Regularly review and update GMP system procedures, as assigned, to ensure alignment with current regulatory standards and company policies.
• Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management.
• Assist in the implementation and maintenance of regulated Quality Systems under the direction of senior QA personnel.
• Support audit preparation activities by organizing documentation, records, and evidence required for inspections and assessments.
• Contribute to continuous improvement initiatives within Quality Assurance and manufacturing quality, including documentation control, inspection activities, and CAPA follow-up.

Essential Skills

• Associate's Degree with relevant experience in a GMP-regulated environment, or a Bachelor's Degree in Life Sciences, Chemistry, Pharmacy, or a related field with 2 years of relevant experience in a GMP-regulated environment.
• Working knowledge of GMP and cGxP regulations as they apply to pharmaceutical manufacturing and quality operations.
• Experience with batch record review, including evaluation of manufacturing, filling, and labeling records.
• Experience with document control processes in a regulated environment.
• Familiarity with deviation management and CAPA processes, including participation in or support of investigations.
• Basic familiarity with FDA, EU, and/or ISO regulatory frameworks.
• Experience in Quality Assurance within pharmaceutical or biotechnology manufacturing.
• Ability to interpret and apply SOPs, specifications, and acceptance criteria to batch and material release.
• Strong attention to detail and accuracy in data entry, tracking, and documentation.
• Ability to identify non-compliance and quality risks and communicate observations clearly to senior staff.
• Comfort working with quality metrics, performance indicators, and reporting tools.
• Ability to work effectively under moderate supervision in a fast-paced, regulated environment.

Additional Skills & Qualifications

• Experience in cell or gene therapy manufacturing or quality operations.
• Experience supporting manufacturing quality in a late clinical-stage biotech or similar environment.
• Exposure to audit preparation and participation in internal, customer, or regulatory audits.
• Experience with CAPA development and follow-up, including root cause analysis and corrective action proposals.
• Familiarity with inspection activities and quality oversight on the production floor.
• Experience with deviations, investigations, and analysis of quality events.
• Interest in contributing to innovative therapies focused on chronic kidney disease and cellular therapies.
• Strong written and verbal communication skills for cross-functional collaboration and documentation review.
• Ability to work collaboratively with Quality Management, production, and other functional teams.

Work Environment

The role is based in both laboratory and office settings within a cleanroom manufacturing environment. The laboratory environment includes Level 10,000 and 100,000 cleanrooms, where the specialist must perform and maintain sterile gowning certification and adhere strictly to cleanroom practices. The position follows a Sunday through Thursday schedule, working from 7:00 a.m. to 3:30 p.m. The work supports the manufacture and quality oversight of an innovative, minimally invasive, percutaneous injectable cell therapy product prepared from patients' own kidney cells, aimed at preserving kidney function and potentially delaying or eliminating the need for dialysis. The environment emphasizes compliance with GMP and cGxP regulations, close collaboration with Quality Operations and manufacturing teams, and participation in a mission-driven culture focused on transforming the therapeutic landscape for chronic kidney disease.

Job Type & Location

This is a Permanent position based out of WINSTON SALEM, NC.

Pay and Benefits

The pay range for this position is $65000.00 - $75000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Will provide company benefits as needed.

Workplace Type

This is a fully onsite position in WINSTON SALEM,NC.

Application Deadline

This position is anticipated to close on Aug 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.