Quality Assurance Specialist

Quality Assurance Specialist

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

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 company requirements, and escalate discrepancies to senior QA staff.
• Report key quality metrics and performance indicators using established templates and reporting tools, ensuring timely and accurate submissions.
• Perform hands-on monitoring of production and non-production activities, identify observed non-compliance, and promptly report issues to Quality Management.
• Support confirmation that finished products conform to internal standards and cGxP regulations, as well as applicable government requirements.
• 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, contribute to root cause identification, and propose corrective actions for review and approval.
• Identify compliance risks, clearly communicate observations to senior management, and support implementation of assigned action plans to mitigate risks.
• Promptly escalate critical quality issues to senior management with appropriate documentation and contextual information.
• 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, including organizing documentation and ensuring readiness of quality records and systems.
• Contribute to continuous improvement initiatives in manufacturing quality, document control, and quality assurance processes within a cell or gene therapy environment.

Essential Skills:

• Associates Degree with relevant experience in a GMP-regulated environment, or a Bachelors Degree in Life Sciences, Chemistry, Pharmacy, or a related field plus 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 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.

Additional Skills & Qualifications:

• Experience in a cell or gene therapy environment, particularly within late clinical-stage or advanced therapy manufacturing.
• Exposure to manufacturing quality activities, including in-process inspections and quality oversight of production operations.
• Experience supporting audit preparation and responding to audit observations in a regulated setting.
• Familiarity with quality metrics reporting and use of established templates and reporting tools.
• Comfort working within a fast-paced, innovative biotech environment focused on novel therapies for chronic diseases.
• Interest in contributing to the development and manufacture of first-in-class cell therapy products aimed at preserving kidney function and potentially delaying or eliminating the need for dialysis.
• Motivation to work on therapies prepared from patients own cells, supporting products that may reduce or eliminate the need for long-term immunosuppressive therapy.

Work Environment:

This role is based in a combination of lab and office settings within a pharmaceutical manufacturing environment focused on cell therapy production. The laboratory work takes place in cleanrooms classified as level 10k and 100k, where controlled conditions and strict adherence to GMP and cGxP are required. The position requires sterile gowning and maintaining certification for sterile gowning, including consistent compliance with cleanroom entry and behavior procedures. You will work with regulated quality systems, documentation tools, and GMP databases, collaborating closely with production, quality, and regulatory teams. The environment is fast-paced and innovation-driven, centered on advanced cellular therapies for chronic kidney disease, with a strong focus on patient impact, regulatory compliance, and high-quality manufacturing standards.

Job Type & Location:

This is a Contract to Hire position based out of WINSTON SALEM, NC.

Pay and Benefits:

The pay range for this position is $34.00 - $38.00/hr. 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. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline:

This position is anticipated to close on Nov 9, 2026.

Workplace Type:

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