GMP QC Analyst - Flow Cytometry

The Quality Control Analyst position involves performing various testing activities to support the Quality Control department, including bio-analytical testing, raw material testing, and protocol testing. The role requires maintaining quality systems and data generated by team members, contributing to investigations, and ensuring compliance with industry standards.

Responsibilities

• Perform routine bioanalytical testing and release of in-process, stability, and final product samples as scheduled.
• Execute routine and non-routine analysis of raw materials, in-process items, and finished products according to established procedures, including Flow Cytometry, ELISA, Kinetic Assays, Cell Counting/Viability, and Visual Appearance.
• Initiate and support deviation and out-of-specification (OOS) investigations in MasterControl.
• Initiate and support action item completion as assigned in MasterControl.
• Initiate and support AQEM activities as assigned in MasterControl.
• Follow Test Methods (TSMs), Standard Operating Procedures (SOPs), Work Instructions (WRKs), and Protocols.
• Author original documents, revisions, and training materials on TSMs, SOPs, WRKs, Test Forms, and Protocols.
• Support QC Analytics with sample receipt.

• Bachelor’s Degree or higher in chemistry, biochemistry, microbiology, or related science.
• 3-5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
• Knowledge of cGMP and understanding of GxP, good clinical practices, and FDA guidelines.
• Familiarity with bioassays and raw material test methods.
• Knowledge of LIMS systems.
• Experience in deviation handling and change control management.
• OOS investigation experience.

• Experience with MasterControl software.
• Familiarity with cleanroom environments and sterile gowning certification.
• Knowledge of cell culture and sterile laboratory techniques.

The position involves working in both a laboratory and office setting. The laboratory is a level 10k and 100k cleanroom environment, requiring sterile gowning and the ability to maintain sterile gowning certification. There are two openings, one for each shift: Sunday to Thursday from 8:30 AM to 5 PM, and Tuesday to Saturday from 8:30 AM to 5 PM.

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 $40.00 - $45.00/hr.

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)

Workplace Type

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

Application Deadline

This position is anticipated to close on Nov 28, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $40 - $45