About the role
JOB PURPOSE
The Quality Control Lab Supervisor (QC Bulk Supervisor) is responsible for overseeing all QC laboratory and in-process
testing activities to ensure raw materials and bulk products meet company quality standards, regulatory requirements,
and customer expectations. This role provides leadership to the QC team, drives continuous improvements, ensures
compliance with cGMP and ISO standards, and partners with cross-functional teams to resolve quality-related issues.
DUTIES & RESPONSIBILITIES
· Lead and supervise the Quality Control stability, raw materials and bulk departments, including chemists, technicians,
and analysts, ensuring optimal performance and adherence to quality standards.
· Oversee all QC activities, including raw material and bulk testing, ensuring accuracy, timeliness, and compliance with
established protocols.
· Develop, implement, and maintain QC policies, procedures, and work instructions in compliance with cGMP, FDA, and
ISO regulations.
· Review and approve test results, certificates of analysis, and related quality documentation prior to product release.
· Manage laboratory investigations for out-of-specification (OOS) and out-of-trend (OOT) results, ensuring root cause
analysis and corrective/preventive actions are implemented.
· Collaborate with Quality Assurance, R&D, Manufacturing, and Supply Chain to address quality concerns and drive
product improvements.
· Oversee method validations, stability studies, and instrument calibration/maintenance programs to ensure accuracy
and reliability of test results.
· Ensure all QC staff are properly trained on lab procedures, safety requirements, and Good Documentation Practices.
· Monitor laboratory performance metrics and implement process improvements to optimize efficiency and cost-
effectiveness.
· Support the QC department budget, including resource planning and procurement of lab supplies and equipment.
· Stay current on regulatory and industry standards, implementing changes as necessary to maintain compliance.
· Prepare and present regular reports on QC performance, trends, and quality metrics to senior leadership.
· Support internal, customer, and regulatory audits by providing QC data, records, and responses to findings.
QUALIFICATIONS
· Bachelor’s degree in Chemistry, Biochemistry, or a related scientific field (Master’s degree preferred).
· 5+ years of experience in quality control or analytical testing, with at least 3 years in a supervisory or management role.
· Strong knowledge of cGMP, FDA, ISO, and other regulatory guidelines.
· Experience in cosmetics, pharmaceuticals, or food manufacturing environments preferred.
· Proficiency with laboratory instrumentation (e.g., pH meter, Viscometer, FTIR) and method development/validation.
· Excellent leadership, analytical, and problem-solving skills.
· Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.
· Proficient in MS Office and laboratory information management systems (LIMS).
PHYSICAL REQUIREMENTS
· Fully on-site expectation, 5 days a week for one shift only.
· Ability to stand for extended periods while working in the lab.
· Capability to lift up to 25 lbs. when handling lab equipment or materials.
· Manual dexterity for operating laboratory instruments and handling small samples.
· Must be able to wear appropriate personal protective equipment (PPE) such as lab coats, gloves, and safety glasses.
Salary Range: $70K to $85K
At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer.