Lead, QC Scientist

Job Description

Job Description

Job Title: Lead QC Scientist Job Description

The Lead QC Scientist oversees and performs analytical testing and data review for raw materials, in-process and finished pharmaceutical dosage forms, stability samples, and cleaning verification samples in accordance with written procedures, compendial methods, and applicable SOPs. This role calculates and reports results against established specifications, leads and participates in method transfer activities within and between facilities or organizations, and provides technical feedback to enhance analytical systems, procedures, and overall compliance. The Lead QC Scientist also provides project leadership to a small group of scientists, offering guidance and support when analytical problems arise.

Responsibilities

• Perform, train, and review chemical analysis of raw materials, in-process and finished pharmaceutical products, including stability samples, using written methods or compendial methods and material specifications, with techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic methods, while strictly adhering to SOPs.
• Prepare samples for analysis using chromatographic techniques, ensuring thorough cleanliness and careful execution of complex preparation steps, and conduct analyses in accordance with established procedures.
• Create and maintain accurate and complete laboratory documentation, including notebooks and computer-based records, clearly describing the steps taken during analysis, and calculate and report results in a timely and compliant manner.
• Review, interpret, and evaluate analytical data generated by co-workers for accuracy, precision, trends, potential GMP impact, and completeness, ensuring that results meet quality and regulatory expectations.
• Demonstrate and promote good laboratory techniques to prevent cross-contamination and misidentification of samples, and prioritize scientists work assignments to support project timelines and deliverables.
• Perform, train, and review physical analyses using complex techniques such as X-ray diffraction, differential scanning calorimetry (DSC), RAMAN spectroscopy, and ICP-MS, ensuring robust and reliable data.
• Lead and actively participate in investigations of out-of-specification (OOS) laboratory results, identifying root causes, recommending corrective actions, and documenting findings in accordance with quality procedures.
• Actively participate in method transfer activities between facilities within the organization or with external organizations, ensuring methods are appropriately verified and implemented.
• Lead and track the execution of method transfer, method verification, and method validation protocols, ensuring timely completion and accurate documentation.
• Assist the laboratory supervisor with non-routine special projects that require laboratory-based activities, providing technical input and hands-on support as needed.
• Ensure expired chemicals and reference standards are identified and removed from laboratory areas in accordance with procedures and good laboratory practices.
• Perform calibration of HPLC and GC instruments as assigned, ensuring equipment remains in a qualified and reliable state for routine testing.
• Interact closely with lab technicians and scientists to provide hands-on training in basic and advanced analytical techniques and laboratory practices, supporting skill development across the QC team.
• Support testing across multiple dosage forms and wet chemistry analyses, contributing expertise in HPLC and other chromatographic and spectrophotometric methods.
• Communicate effectively with QC colleagues and technical staff to coordinate testing activities, share analytical insights, and maintain alignment with project and departmental goals.

Essential Skills

• Bachelors degree (BA/BS) in Chemistry or a related science discipline is required.
• Masters degree (MS/MA) in Chemistry or a related science discipline is preferred.
• At least 5 years of experience testing pharmaceutical products with a bachelors degree, including a minimum of 1 year leading or supervising projects.
• At least 3 years of experience testing pharmaceutical products with a masters degree.
• At least 1 year of experience leading projects in a laboratory or quality control setting.
• In-depth knowledge of analytical chemistry techniques, including spectrophotometric methods, dissolution and drug release testing, and chromatographic techniques (standalone or hyphenated).
• Hands-on experience with IR spectroscopy, UV-Vis spectroscopy, HPLC, GC, and wet chemistry techniques applied to pharmaceutical analysis.
• Experience testing multiple pharmaceutical dosage forms in a QC environment.
• Proficiency in measuring physical parameters such as viscosity, particle size or droplet size by laser diffraction, and melting point determination by DSC.
• Ability to perform and interpret complex physical analyses using techniques such as X-ray diffraction, DSC, RAMAN spectroscopy, and ICP-MS.
• Strong ability to follow and apply compendial procedures (USP, EP, BP, JP) for analytical testing.
• Solid understanding and practical application of cGMP requirements as they relate to quality control laboratories.
• Demonstrated ability to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner, and to report actions and outcomes to laboratory management.
• Ability to identify trends in analytical data and assess potential quality and GMP impacts.
• Strong documentation skills, with the ability to maintain detailed, accurate, and compliant laboratory records in both paper and electronic formats.
• Demonstrated capability to review and evaluate analytical data generated by others for accuracy, precision, completeness, and adherence to specifications.

Additional Skills & Qualifications

• Experience leading small project teams or groups of scientists within a QC or analytical laboratory environment.
• Experience participating in and leading method transfer, method verification, and method validation activities between facilities or organizations.
• Familiarity with cleaning verification testing and stability studies for pharmaceutical products.
• Experience calibrating and maintaining analytical instruments such as HPLC and GC in a regulated environment.
• Ability to provide hands-on training and mentorship to lab technicians and scientists in basic analytical techniques, wet chemistry, and laboratory best practices.
• Strong organizational skills to prioritize multiple testing assignments and project needs within a busy QC department.
• Effective communication skills to collaborate with QC team members, technical staff, and cross-functional partners.
• Attention to detail and commitment to continuous improvement of laboratory systems, analytical procedures, and compliance posture.

Work Environment

This position is based within a quality control department of a global biopharmaceutical organization that develops and delivers a diverse portfolio of generic and specialty pharmaceuticals. The QC team consists of approximately 15 professionals working collaboratively in a regulated laboratory setting focused on testing a wide range of pharmaceutical dosage forms. The environment emphasizes adherence to cGMP, compendial standards, and robust analytical practices using techniques such as HPLC, GC, IR, UV-Vis, X-ray diffraction, DSC, RAMAN, and ICP-MS. The Lead QC Scientist works closely with technical staff and QC colleagues in a structured, project-driven environment that values teamwork, data integrity, and continuous improvement.

Job Type & Location

This is a Contract position based out of PISCATAWAY, NJ.

Pay and Benefits

The pay range for this position is $43.00 - $53.00/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)

Workplace Type

This is a fully onsite position in PISCATAWAY,NJ.

Application Deadline

This position is anticipated to close on Oct 15, 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 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 us.fitly.work 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.