Quality Control Lab Supervisor

Job Description:

The ARM Group LLC is looking to hire a Full-Time Quality Control Lab Supervisor for one of our clients located in Aurora, IL.

#Immediate Hiring

#Salary Range: $75K-$110k/Annually

Key Responsibilities:

• Lead and co-ordinate daily operations of the QC laboratory, including sampling and testing of raw materials, packaging components, in-process, finished products, and stability samples for cosmetic and OTC drug products across all 3 shift operations.
• Ensure all test methods are validated, and QC Lab operates in compliance with ISO 17025, ISO 22716, MoCRA and 21 CFR Parts 210 & 211, USP, and internal specifications.
• Prepare, review & approve all the SOPs for QC Lab operations and ensure its effective deployment. Review & approve RM, PM, FG Specifications, in coordination with clients and/or R&D.
• Be responsible for the qualifications of the external laboratories and co-ordinate all the outsourced testing in an efficient (cost and lead time) & compliant manner.
• Supervise and support the team of analysts, providing them with the required training, technical guidance, and performance feedback to build a capable & reliable QC team.
• Review and approve the testing data, test reports (COA), and laboratory documentation for accuracy, completeness, integrity and regulatory compliance. Ensure timely disposition decision for RM, PM & FG in SAP.
• Maintain and ensure the qualification, calibration, and preventive maintenance of laboratory instruments/equipment.
• Investigate laboratory deviations, OOS results, and other non-conformances; support root cause analysis and CAPA implementation to avoid recurrence.
• Manage sample retention, reference/working standards, and inventory of lab chemicals, reagents, glassware, spares & consumables to support uninterrupted lab operations.
• Maintain all standard validated test methods, test reports, certificate of analysis/conformance and other laboratory records (paper based or electronic) in a manner that facilitates easy archival & retrieval and meets the FDA requirements.
• Ensure test method development, validation, and transfer activities, as & when needed.
• Deploy effective statistical Quality Control (SQC) checks and measures on the shop floor to meet the product quality standards on an ongoing basis.
• Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and data integrity (ALCOA+) requirements.
• Participate and assist during client audits and regulatory inspections; ensure audit readiness of all lab systems and documentation.
• Monitor and report lab KPIs such as turnaround times, repeat testing, and OOS trends to the management with a mindset of continuous improvement.
• Ensure adequate safety training for all lab analysts to maintain a safe working environment in the lab.
• Disclaimer:
• ARM GROUP is committed to fostering a diverse and inclusive workplace. We are an Equal Employment Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.
• We actively encourage applications from individuals with diverse backgrounds, including people with disabilities. Accommodations are available upon request for applicants participating in all aspects of the selection process.
• By applying for this job, you consent to allow representatives of ARM GROUP LLC to contact you regarding your candidacy. This may include communication via email, phone, text, or other means deemed appropriate by ARM GROUP LLC. Rest assured, your information will be handled confidentially and used solely for recruitment purposes.
• It’s important to note that ARM Group LLC does not interfere in the decision-making process regarding your selection or rejection. The ultimate decision to hire or reject your candidacy lies solely with the client organization, with whom we have an agreement to source candidates for their consideration
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. All applicants must submit to background check and drug screening. Applicants for this position must be legally authorized to work in the United States. Please be aware that this position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.