Job Description
Job Description
Job Summary:
The Lab Coordinator is responsible for managing daily operations within the Quality Control laboratory, while also acting as a critical liaison between the company and external laboratories. This role ensures timely and compliant sample submissions, tracks test progress, and follows up on delayed or problematic results. In addition to sample coordination, this position plays a key role in out-of-specification (OOS) investigations by collaborating with labs to evaluate test methodologies and analytical validity. The Lab Coordinator supports the issuance of Certificates of Analysis (CofAs), provides guidance to lab technicians, and helps oversee raw material and finished product testing schedules. This role requires strong analytical acumen, attention to detail, and the ability to manage lab workflows effectively.
Job Duties and Responsibilities:
Laboratory Operations & Oversight
- Coordinate lab testing priorities and workflows in alignment with production schedules.
- Provide guidance and scheduling coordination for lab technicians involved in sampling and testing of raw materials, in-process samples, and finished products.
- Monitor lab activities for compliance with SOPs, GMP, and FDA regulations.
- Maintain laboratory logs, test records, and documentation in accordance with GMP and FDA requirements
- Act as the primary point of contact for external laboratories regarding sample status, issues, and timelines.
- Track sample submissions, confirm receipt, and follow up on any delays or discrepancies.
- Ensure clear documentation and traceability of all sample shipments and lab communications.
Out-of-Specification (OOS) Investigations
- Support and lead OOS investigations related to raw materials and finished goods, as applicable.
- Work closely with labs to assess the appropriateness and validity of test methodologies.
- Assist in root cause analysis and documentation of OOS findings in accordance with regulatory expectations.
Quality Control & Documentation
- Review and issue Certificates of Analysis (CofAs) for finished goods; ensure alignment with specifications and customer requirements.
- Maintain accurate, complete, and audit-ready documentation of test results and quality activities.
- Support internal investigations, CAPAs, and deviation reports as needed.
Equipment & Inventory Management
- Ensure laboratory equipment is maintained, calibrated, and fit for use.
- Monitor and order laboratory supplies, ensuring availability for ongoing testing.
- Oversee proper handling and storage of chemicals, reagents, and retained samples.
Compliance & Training
- Promote a safe, compliant, and inspection-ready laboratory environment.
- Assist with onboarding and training of lab staff in testing procedures and documentation standards.
- Support internal and third-party audit readiness.
- Ensure all activities are conducted in compliance with GMP, FDA, and company SOPs.
Job Requirements:
- Associate or bachelor’s degree in a science-related field (chemistry, biology, food science) required.
- 2–4 years of experience in a quality control laboratory, preferably in the nutraceutical, pharmaceutical, or food manufacturing industry.
- Strong analytical background with the ability to assess lab methods and interpret technical data.
- Familiarity with GMP, FDA regulations, and laboratory best practices.
- Excellent organizational and communication skills for managing lab coordination and external interactions.
- Proficient in Microsoft Office (Excel, Word, Outlook).
- Proficiency in reading and writing English in accordance with FDA recordkeeping standards.
- Strong attention to detail with excellent critical thinking skills.
- Competency in basic math and use of formulas: addition, subtraction, multiplication, division, and percentages.
- Environmental expectations: lab (GMP) environment, PPE Requirements, may need to physically lift up to 20 lbs., standing for long periods of time.
Benefits:
- Medical
- Dental
- Vision
- 401K with company match
- PTO
- 11 Paid Holidays
- Breakfast provided Monday - Friday