QC Analyst II

Job Description

Job Description

Job Title: QC Analyst II

Job Description

The QC Analyst II performs routine and complex analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples in a small pharmaceutical laboratory setting. This role follows cGMP documentation and work instructions with precision, sets up and operates advanced analytical instrumentation, and supports the release and ongoing quality monitoring of intermediates and active pharmaceutical ingredients. The QC Analyst II works with minimal supervision, contributes to technical problem-solving and documentation, and helps ensure compliance with regulatory and internal quality standards.

Responsibilities

• Follow cGMP documentation, procedures, and work instructions accurately and completely for all laboratory activities.
• Perform routine analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples using established test methods and procedures.
• Execute routine laboratory functions such as weighing using balances, preparing solutions, pipetting, and using pH meters with an in-depth understanding of these core activities.
• Perform complex analyses using techniques and instrumentation including appearance testing, FT-IR, UPLC, HPLC, HPLC-ELSD, GC, and GC-HS.
• Conduct routine testing to support the release of raw materials, intermediates, and APIs, including testing for in-process controls, equipment cleaning verification, reference standard qualification, and stability programs.
• Perform and assist with the coordination of monthly or quarterly environmental monitoring testing in the laboratory.
• Coordinate and facilitate the shipment of samples to external vendors for specialized or additional testing.
• Set up and configure various analytical instruments for testing according to written test methods with little to no supervision.
• Demonstrate proficiency in operating and troubleshooting HPLC, GC, FT-IR, and related analytical equipment.
• Plan and execute analytical testing activities independently, ensuring work is completed with minimal supervision.
• Perform all assigned analyses in a timely, efficient, and organized manner to meet testing and release timelines.
• Show initiative and interest in learning new analytical techniques, methods, and tests to expand laboratory capabilities.
• Participate actively in technical discussions and brainstorming sessions to resolve issues and improve laboratory processes.
• Identify and troubleshoot analytical problems related to instrumentation, general chemistry, test methodologies, and submitted samples.
• Communicate analytical issues, challenges, and findings clearly to staff and management as needed.
• Review test data generated by other analysts and witness entries in others laboratory notebooks to support data integrity.
• Initiate, review, and assist in the completion of technical documentation such as out-of-specification (OOS) and atypical investigations, deviations, and corrective and preventive actions (CAPAs).
• Perform routine laboratory and glassware cleaning to maintain a safe, organized, and compliant work environment.
• Handle controlled substances in accordance with applicable procedures and regulatory requirements.
• Ensure timely completion of all required cGMP and other relevant company training and maintain ongoing compliance with quality and regulatory standards.

Essential Skills

• Demonstrated ability to follow cGMP documentation and work instructions accurately and completely.
• Hands-on experience performing routine analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples.
• Strong practical skills in core laboratory techniques including weighing and balance use, solution preparation, pipetting, and pH meter operation.
• Proficiency with analytical chemistry techniques such as HPLC and Karl Fischer (KF) titration.
• Experience performing complex analyses using FT-IR, UPLC, HPLC, HPLC-ELSD, GC, and GC-HS instrumentation.
• Ability to set up and operate HPLC, GC, FT-IR, and related instruments with minimal supervision.
• Competence in planning and executing analytical testing independently while meeting timelines.
• Skill in identifying and troubleshooting analytical problems involving instrumentation, general chemistry, test methodologies, and sample issues.
• Experience reviewing analytical test data generated by others and witnessing laboratory notebook entries to support data integrity.
• Knowledge of and experience with technical documentation related to OOS and atypical investigations, deviations, and CAPAs.
• Understanding of GMP principles and practices within a pharmaceutical laboratory environment.
• Ability to handle controlled substances in accordance with established procedures and regulatory expectations.

Additional Skills & Qualifications

• Experience performing and coordinating environmental monitoring testing on a monthly or quarterly basis.
• Experience in protocol review related to analytical testing or qualification activities.
• Strong organizational skills to manage multiple tests, sample shipments, and documentation requirements efficiently.
• Effective communication skills to collaborate with leadership, management, and external testing vendors.
• Demonstrated initiative and curiosity in learning new analytical techniques and methods.
• Ability to participate constructively in technical discussions and brainstorming sessions aimed at continuous improvement.
• Attention to detail and commitment to data integrity and accurate record-keeping in laboratory notebooks and reports.

Work Environment

This position is based on site in a small pharmaceutical laboratory operating during standard business hours. The work environment involves regular use of analytical instruments such as HPLC, UPLC, GC, GC-HS, FT-IR, pH meters, balances, and equipment for Karl Fischer titration. Work is performed in a regulated GMP setting with an emphasis on safety, cleanliness, and compliance. The role requires frequent interaction with laboratory equipment, chemical reagents, and controlled substances, as well as coordination with external testing vendors. The setting supports collaborative technical discussions while maintaining a focused, detail-oriented atmosphere.

This is a Contract position based out of Cary, NC.

The pay range for this position is $30.00 - $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 position based out of Cary, NC.

This position is anticipated to close on Oct 26, 2026.

This is a fully onsite position in Cary,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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.