Quality Assurance Specialist I

Job Description

Job Description

Job Title: Quality Assurance Specialist I Job Description

The Quality Assurance Specialist I provides essential support to Quality Operations, focusing on material and batch release activities. Working within established GMP processes and under moderate supervision, this role ensures compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. The successful candidate will apply their developing professional knowledge, attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities in a fast-paced pharmaceutical environment.

• 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 escalate 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.

• Bachelors 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 escalate 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.

The role involves working in a lab and office setting. The lab is a cleanroom with level 10k and 100k cleanroom conditions. The candidate will be responsible for sterile gowning and maintaining certification for sterile gowning.

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

The pay range for this position is $26.00 - $32.00/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)

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

This position is anticipated to close on Nov 17, 2026.

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

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 View email address on ziprecruiter.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.