Quality Assurance Specialist I

Actalent; Winston-Salem (NC); On-site; USD 36,000 - 44,000; Full time

Benefits offered by this job

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

Job summary

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.

Responsibilities

• 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.

Skills

Foundational cGMP & data integrity

Follow detailed procedures

Attention to detail & communication

MS Word & Excel proficiency

Education

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

Tools

Electronic quality/document management systems

Job description

Job Title: Quality Assurance Specialist I

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.

Responsibilities

• 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.

Essential Skills

• 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 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.

Additional Skills & Qualifications

• Exposure to electronic quality or document management systems preferred.
• Experience in cell or gene therapy and manufacturing quality.
• Audit preparation, investigation, and analysis capabilities.

Work Environment

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.

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 $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.

• 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 6, 2026.

Workplace Type

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 [e-mail] 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.