Associate Quality Control

Job Description

Job Description

Job Title: Associate, Quality Control (QC) Chemistry
Job Description

This role supports the startup and ongoing operational readiness of a GMP-regulated Quality Control (QC) chemistry laboratory. The Associate, Quality Control (QC) Chemistry works with minimal supervision to qualify systems, transfer analytical methods, and ensure robust laboratory operations that support pharmaceutical and biopharmaceutical manufacturing. The position focuses on analytical testing, technical documentation, and cross-functional collaboration to maintain a compliant, audit-ready laboratory environment.

Responsibilities

• Support the startup and operational readiness of the QC chemistry laboratory in a GMP-regulated environment.
• Collaborate cross-functionally with site teams to implement work order and preventative maintenance systems for laboratory equipment.
• Review and contribute to validation documentation to support onboarding of laboratory equipment and computerized systems.
• Draft, revise, and review technical and quality documentation, including standard operating procedures (SOPs), test methods, technical assessments, validation reports, trend reports, and safety evaluations.
• Assist in the procurement and management of laboratory consumables and critical reagents required for startup and routine activities.
• Coordinate and execute training and method transfer activities for analytical instruments, including HPLC/UPLC, TOC, conductivity, osmolality, and other chemistry-based platforms.
• Perform laboratory testing of manufactured materials in accordance with GMP, compendial methods, and internal procedures.
• Provide training on new analytical methods and ensure proper documentation and knowledge transfer.
• Actively participate in audits, quality initiatives, and cross-functional projects with site or global impact.
• Maintain audit readiness by ensuring documentation, data, and laboratory practices comply with regulatory and internal standards.
• Support method validation, verification, and transfer activities to ensure analytical methods are robust and compliant.
• Provide routine operational support during weekends and public holidays as needed to sustain laboratory operations.
• Contribute to continuous improvement of laboratory processes, systems, and documentation to enhance efficiency and compliance.
• Support startup activities by helping to establish laboratory workflows, systems, and procedures.

• Bachelor's degree or higher in Chemistry, Compendial Testing, or a related scientific discipline.
• Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment.
• Strong background in analytical testing within a QC chemistry setting.
• Proficiency in analytical laboratory techniques and instrumentation, including HPLC/UPLC, TOC, conductivity, and osmolality platforms.
• Demonstrated chemistry background with hands-on experience in QC or analytical laboratories.
• GMP experience with a clear understanding of working in a regulated pharmaceutical or biopharmaceutical environment.
• Experience using Empower or similar chromatography data systems.
• Familiarity with laboratory systems such as LIMS and LMES/CIMS.
• Demonstrated understanding of industry regulations, data integrity principles, and compliance standards.
• Strong technical writing and documentation skills for SOPs, test methods, validation reports, and related documents.
• Effective written and verbal communication skills to support cross-functional collaboration and documentation.
• Experience with method validation, method verification, and method transfer activities.
• Ability to work with minimal supervision while managing multiple tasks in a dynamic laboratory environment.
• Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.

• Experience supporting laboratory startup activities, including system qualifications and operational readiness.
• Exposure to compendial testing and pharmacopeial methods.
• Experience participating in internal or external audits and quality initiatives.
• Demonstrated ability to maintain audit readiness through consistent documentation and compliance practices.
• Experience coordinating and delivering training on analytical methods and laboratory systems.
• Strong organizational skills to manage documentation, consumables, and multiple concurrent projects.
• Ability to adapt to changing priorities and support cross-functional projects with site or global impact.

This position is fully onsite in a GMP-regulated QC laboratory environment. Standard working hours apply, with the expectation of up to five days per month requiring shift flexibility to support operational needs. The role may require providing routine operational support during weekends and public holidays. The laboratory uses advanced analytical technologies, including HPLC/UPLC, TOC, conductivity, osmolality, and computerized systems such as Empower, LIMS, and LMES/CIMS. The environment emphasizes audit readiness, data integrity, and strict adherence to GMP and safety procedures, with appropriate laboratory attire and personal protective equipment required at all times.

Job Type & Location

This is a Contract position based out of Holly Springs, NC.

The pay range for this position is $28.00 - $32.00/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)

This is a fully onsite position in Holly Springs,NC.

This position is anticipated to close on Jun 16, 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 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 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.