Quality Control Specialist

Job Title:  Quality Control Specialist

FLSA:  Non-Exempt

Department:  Quality

Reports To:  Quality Director

Remote Eligibility:  Not Remote Eligible — laboratory and production floor presence is required.

Position Summary

The QC Specialist performs the routine testing, inspection, and documentation that verify CMC products meet quality and regulatory requirements. Working under the direction of the QC Manager and within established SOPs, this role examines raw materials, in-process samples, and finished products, maintains laboratory equipment and records, and promptly reports any result that falls outside specification. Accuracy, timeliness, and disciplined record-keeping are the core accountabilities of the position. The QC Specialist supports basic QA activities as a secondary, cross-trained responsibility and contributes to CMC’s mission through Collaboration, Character, and Commitment in day-to-day quality work.

Essential Duties and Responsibilities

• Perform routine physical, chemical, and in-process testing of raw materials, in-process samples, and finished products following established SOPs and USP methods.
• Conduct in-process and first-unit inspections of compounding and filling operations against approved specifications.
• Collect, label, and maintain representative samples of all lots produced, including retains for raw materials and finished goods.
• Execute routine stability sample pulls and record stability chamber conditions (temperature, humidity) in accordance with ICH-aligned protocols.
• Record test results and observations accurately and contemporaneously, following good documentation practices (GDP).
• Prepare and file documentation associated with receipt and testing of products, components, and materials, including Certificates of Analysis for finished product.
• Perform routine calibration, maintenance, and verification of laboratory equipment, and maintain associated logs.
• Immediately escalate and report out-of-specification results, deviations, or potential quality issues to the QC Manager or designee.
• Maintain laboratory cleanliness, organization, and consumable supply inventory; follow assigned cleaning task lists.
• Identify and report safety hazards; follow all safety, PPE, and chemical-handling requirements (GMP, ISO 22716, OSHA).
• Provide cross-trained support to QA and other QC functions as directed during absences or peak demand.
• Performs other duties as assigned.

Education and/or Experience

Required:

• High school diploma or GED, or an associate degree in a science-related field, or an equivalent combination of education and experience.
• Familiarity with GMP and ISO standards in a manufacturing environment.

Preferred:

• B.S. in Chemistry, Biology, or a related scientific field.
• One or more years of laboratory or quality control experience in a chemical, pharmaceutical, or consumer-goods manufacturing environment.

Required Skills and Competencies

• Working knowledge of basic laboratory techniques and instrumentation (e.g., pH, titration, viscosity, balances) and standard sampling methods.
• Ability to read and follow SOPs, specifications, and safety data sheets (SDSs) accurately.
• Proficiency in Microsoft Office (Excel, Word, Outlook); exposure to LIMS or ERP systems is a plus.
• Strong attention to detail with accurate, consistent, and timely record-keeping.
• Effective time management and the ability to multi-task and prioritize routine work.
• Clear written and verbal communication and a collaborative, team-oriented approach.
• Comfort working in a manufacturing environment with exposure to chemicals and industrial equipment, including standing for extended periods.
• Position follows the production schedule of 5:30 AM to 4:00 PM, Monday through Thursday, with occasional Fridays; flexibility to work additional shifts, including evenings and weekends, may be required as needed.