QC Data Reviewer

Job Title:

QC Data Reviewer - Chemistry Job Description The QC Data Reviewer oversees a team of approximately 14-20 chemists and laboratory technicians who test finished products, raw materials, in‑process samples, components, and stability study samples for pharmaceutical products. This role focuses on detailed data review, ensuring data integrity and compliance with GMP and FDA guidelines, and supporting audits and investigations related to daily testing activities. The position is heavily involved with new ANDA oral dose products, including oral rinses and antiseptic solutions, and occasionally provides hands‑on support with analytical testing in the QC laboratory. Responsibilities Oversee and support 14-20 chemists and laboratory technicians performing QC testing on finished products, raw materials, in‑process samples, components, and stability study samples. Review analytical data generated in the QC laboratory to ensure accuracy, completeness, and compliance with ALCOA and ALCOA+ data integrity principles. Conduct thorough documentation and audit trail reviews, including electronic records, to verify traceability and data integrity. Perform detailed data review for testing related to new ANDA products, primarily within the oral dose portfolio such as oral rinses and antiseptic solutions. Check and verify the work of chemists using techniques such as titrations, pH measurements, specific gravity, and HPLC for a variety of pharmaceutical samples. Assist with hands‑on testing in the QC laboratory as needed, including

HPLC, GC, TOC, FT

‑IR, UV‑Vis, pH meters, and other analytical instrumentation. Inspect supplies and ingredients used for the production of pharmaceutical products to ensure they meet quality specifications. Review standard operating procedures (SOPs) and laboratory protocols for accuracy, clarity, and compliance with regulatory and internal requirements. Support and participate in laboratory investigations and deviation assessments, contributing to root cause analysis and corrective and preventive actions. Assist with instrument validation activities as needed, ensuring equipment is qualified and maintained in a state of control. Ensure all laboratory documentation, including notebooks and electronic records, is complete, legible, and compliant with GMP and GDP expectations. Adhere strictly to GMP, GDP, and FDA guidelines in all QC laboratory operations and data review activities. Collaborate with quality assurance and other cross‑functional teams to support audits, inspections, and continuous improvement initiatives. Utilize LIMS, OpenLab, and other laboratory software systems to review, track, and manage analytical data and documentation. Contribute to a culture of quality, data integrity, and continuous improvement within the QC laboratory. Essential Skills 3-5+ years of hands‑on HPLC and GC experience in a pharmaceutical or cGMP environment. Experience in the pharmaceutical or life sciences industry, with biotech or pharma strongly preferred. 2+ years of audit trail review experience, preferably using systems such as OpenLab, MasterControl, and/or LabX. Strong knowledge and practical application of ALCOA and ALCOA+ data integrity principles. Bachelor's degree with a major in Chemistry. Preferred minimum of 4 years of pharmaceutical industry experience with hands‑on

GC, HPLC, FT

‑IR, and wet chemistry (including titrations). Good working knowledge of GMP and GDP requirements for laboratory operations and documentation. Proficiency in documentation review, including laboratory notebooks, electronic records, and supporting QC documentation. Ability to interpret and evaluate analytical data from chromatography and other analytical techniques. Strong computer skills, including experience with Microsoft Office and laboratory informatics systems. Clear, legible handwriting suitable for laboratory notebook documentation. Experience with investigations, deviations, and quality assurance processes in a regulated environment. Additional Skills & Qualifications Experience with Agilent OpenLab software for chromatography data acquisition and review. Familiarity with LIMS and other QC laboratory data management systems. Analytical chemistry, wet chemistry, and chromatography in a QC setting. Understanding of FDA regulations and expectations related to data integrity and audit trails. Experience with quality assurance activities, including audits and inspection readiness. Strong attention to detail and ability to maintain high standards of data integrity and traceability. Effective communication skills to collaborate with laboratory staff, quality assurance, and cross‑functional teams. Ability to work independently while providing oversight and support to a team of chemists and lab technicians. Interest in career growth into higher‑level QA roles or laboratory support and management positions within a growing organization. Work Environment The role is based in a QC laboratory within a rapidly growing pharmaceutical organization that specializes in oral rinse and antiseptic solutions, as well as other oral dose pharmaceutical products, including newly acquired ANDA products. The environment is highly regulated and cGMP‑compliant, with a strong focus on data integrity, documentation, and quality. You will work with a range of analytical instruments and technologies, including

HPLC, GC, TOC, FT

‑IR, UV‑Vis, pH meters, and chromatography data systems such as Agilent OpenLab, as well as LIMS and other laboratory software. The company is expanding its laboratory footprint, including new lab facilities, offering opportunities for professional growth and advancement into higher‑level QA or lab support roles. The standard work schedule is on first shift, typically 8:00 AM to 4:00 PM or 9:00 AM to 5:00 PM in a professional laboratory setting. Job Type & Location This is a Contract to Hire position based out of Mount Prospect, IL. Pay and Benefits The pay range for this position is $34.00 - $36.00/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 Mount Prospect,IL.

Application Deadline This position is anticipated to close on May 27, 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 actalentaccommodation@actalentservices.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.