Director of Quality Control

Summary: The Director of Quality Control is responsible for managing all aspects of laboratory operations related to raw materials, in-process materials, and finished product testing for nutraceutical products. This includes oversight of analytical chemistry and microbiological testing functions supporting CAPTEK’s manufacturing operations, prioritizing with production schedules across three sites. The role ensures compliance with applicable regulatory requirements, including 21 CFR 111, 21 CFR 117, and Good Laboratory Practices (GLP), and drives continuous improvements in laboratory efficiency, compliance, and data integrity. This position is centrally based in the Cerritos, CA facility.

Essential Duties and Responsibilities:

· Leads and manages centralized laboratory personnel including analytical chemists and microbiologists

· Oversee daily testing operations involving methods such as HPLC, FTIR, ICP-MS, Atomic Absorption (AA), and wet chemistry, as well as microbiological methods for TPC, coliforms, E. coli, yeast & mold, Salmonella, and Listeria

· Ensures compliance with FDA regulations (21 CFR 111/117), GLP standards, and internal SOPs for all laboratory testing activities

· Establishes and maintains laboratory workflows to streamline sample logging, prioritization, and testing schedules for all three manufacturing sites

· Develops and monitors key performance indicators (KPIs) to track lab efficiency, turnaround time, and compliance metrics

· Reviews and approves analytical and microbiological test results for raw materials, in-process samples, and finished goods

· Drives method development and method validation programs with a goal of attaining ISO 17025 certification for the central lab

· Implements and oversees laboratory documentation practices to ensure data integrity, traceability, and audit readiness

· Participates in cross-functional meetings to align testing timelines with production schedules and quality release requirements

· Leads and manages the Environmental Monitoring Program for the three facilities

· Coordinates with Quality Assurance, R&D, Procurement, and Operations on product specifications, investigations, and process improvements

· Provides scientific leadership and technical guidance to lab staff; ensures ongoing training and professional development

· Prepares and maintains all necessary documentation to support external audits and regulatory inspections

· Leads or supports investigations, deviations, and out-of-specification (OOS) events involving laboratory testing or results

Qualifications:

· Strong knowledge of analytical and microbiological testing methods applicable to food and dietary supplement products

· Experience managing laboratory teams in a cGMP-compliant environment

· Familiarity with regulatory frameworks including 21 CFR 111, 21 CFR 117, and GLP

· Proven track record in method development, validation, and regulatory submission documentation

· Strong organizational, leadership, and interpersonal skills with the ability to work cross-functionally

· Excellent written and verbal communication skills; able to clearly present technical information

· Experience with laboratory systems (e.g., LIMS) preferred

· Knowledge of herbal, botanical, and food-grade raw materials is highly preferred

Education/Experience:

· Bachelor’s degree in Chemistry, Microbiology, Food Science, Pharmaceutical Sciences or related scientific discipline required

· Master’s degree or Ph.D. preferred

· Minimum of 7–10 years experience in a regulated laboratory setting (nutraceutical, food, pharmaceutical)

· Minimum of 5 years leadership experience managing multidisciplinary laboratory teams

· Experience with ISO 17025 accreditation and method validation required

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee may be exposed to laboratory environments involving chemicals, biological samples, and analytical equipment. The noise level in the work environment is typically moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical demands require sitting, walking, bending, reaching, and occasionally lifting objects up to 25 pounds. Specific vision abilities include close vision, color vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to handle objects, reach with hands and arms, and communicate verbally.

I understand the requirements of this position and acknowledge I can perform all essential job functions with or without reasonable accommodations.

EEOC Statement

CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants.

We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.