Quality Control Analyst

The Quality Control Biochemistry Analyst 2 is tasked with performing both routine and specialized biochemistry testing within a dynamic, FDA-regulated medical device and diagnostics environment. This role is crucial in supporting laboratory operations through testing, documentation, training, and participating in continuous improvement initiatives.

Responsibilities

• Conduct biochemistry testing of raw materials, intermediates, special test requests, and finished product samples following standard operating procedures (SOPs).
• Document and review test results to ensure accuracy, completeness, and compliance with Good Documentation Practices (GDP).
• Provide support and input for Out of Specification (OOS) and laboratory investigation reports, including documentation of invalid test results.
• Prepare for and participate in regulatory, customer, and internal audits by maintaining logbooks, instrument calibration records, and ensuring laboratory cleanliness and compliance.
• Serve as a certified trainer for laboratory testing processes and instrument maintenance.
• Train and mentor teammates on biochemistry laboratory procedures and SOPs.
• Troubleshoot and resolve routine to moderately complex laboratory equipment issues.
• Enter data into the Laboratory Information Management System (LIMS) and assist with its maintenance and validation activities.
• Contribute to the revision and improvement of QC department SOPs.
• Maintain personal training records and ensure ongoing compliance with departmental processes.
• Consistently utilize appropriate Personal Protective Equipment (PPE) for all laboratory activities.
• Adhere to Health, Safety, and Environmental (HSE) requirements.
• Participate in laboratory and organizational continuous improvement initiatives.
• Maintain laboratory areas in accordance with 6S principles (Sort, Set in order, Shine, Standardize, Sustain, Safety) to ensure a clean, organized, and compliant workspace.
• Collaborate with other departments to execute validation protocols for laboratory equipment, software, and procedures.
• Perform additional duties as assigned by management to support laboratory operations.

• Bachelor’s degree (BS/BA) in Biology, Chemistry, Biochemistry, or a related discipline.
• Experience in a regulated laboratory environment (FDA, GLP, GMP, CLIA, CAP) preferred.
• Strong attention to detail and commitment to quality.
• Effective communication and teamwork skills.
• Ability to train and mentor others.
• Familiarity with LIMS and laboratory documentation systems.

• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
• Method validation experience.

This position offers the opportunity to play a key role in ensuring the quality and compliance of biochemistry laboratory operations, with a focus on continuous improvement and professional development. The environment is fast-paced, requiring adherence to safety standards and the use of appropriate Personal Protective Equipment (PPE).

Job Type & Location

This is a Contract position based out of Durham, North Carolina.

Pay and Benefits

The pay range for this position is $40.00 - $40.00/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 Durham,NC.

Application Deadline

This position is anticipated to close on Oct 10, 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