QA Supervisor-DICP

Well EnterprisesDunkirk, NY
Onsite

About The Position

The Quality Supervisor is responsible for monitoring production and coordinating the activities of Laboratory Technicians and operations personnel involved in inspecting materials and ensuring that they meet the quality standards specified by the company. This role involves training employees in SOPs, safety topics, testing procedures, and quality procedures, as well as monitoring QA final acceptance, product holds, and materials review. The supervisor also performs GMP audits, documents and enforces HACCP, GMPs, SSOPs, and SOPs, and conducts various inspections and testing, including raw material inspections, pre-op and in-operational inspections, and monthly air monitoring. Additionally, the role includes maintaining daily reports, assisting with KPI reports, working with sanitation, conducting annual validations, verifying incoming documentation, maintaining registries, inspecting facility glass and plastic, and supporting internal and external audits. The QA Supervisor interacts with auditors and assists management with special projects.

Requirements

  • Bachelors degree in Food Science, Microbiology, Business Administration, Education, Technology, or Communications, OR equivalent (year for year) experience with food or nutritional products manufacturing/retail firms in manufacturing or quality programs.
  • Minimum of 5 years demonstrated experience, preferably within a quality assurance/control role, in a medical product, food or nutritional product manufacturing or retail setting.
  • Previous experience in an FDA/USDA regulated industry.
  • Process Controls Qualified Individual (PCQI), Hazard Analysis Critical Control Point (HACCP) and Safe Quality Foods (SQF) certification required. If not acquired prior to accepting the position, must attain PCQI, HACCP and SQF certification within one year in role.
  • Demonstrated knowledge of manufacturing equipment, systems and tools, as well as, productivity principles and practices.
  • Familiarity with Food Hygiene, basic Food Microbiology, Food Organoleptic Assessment, Production Processes, Batch Process Documentation, Quality tools, Material flow and management.
  • Knowledgeable in the areas of safe work practices and GMPs.
  • Previous experience with effective labor planning and scheduling and procedure writing.
  • Demonstrated leadership skills (creating effective teams, driving change, managing accountability).
  • Strong problem solving and decision-making skills.
  • Good attention to detail and ability to prepare and give written and oral instructions.
  • Multi-project/multi-tasking capability.
  • Proficient skill in using Microsoft Office software (Excel, Outlook, Word, PowerPoint, etc).
  • Demonstrated ability in Fundamental math skills.
  • Ability to establish strong relationships at all levels of the organization.
  • Ability to understand the overall business operation and the impact of decisions, performance and behavior.
  • Ability to effectively listen, offer solutions and resolve concerns/issues.
  • Ability to work in a collaborative environment.
  • Ability to establish and shift priorities as needed.
  • Ability to organize and coordinate multiple tasks and to work under time constraints to meet deadlines.
  • Ability to translate theory into practical applications.

Nice To Haves

  • Manufacturing Equipment Qualification
  • Project Management
  • Familiarity with (FDA & USDA 21CFR & 7 CFR or even 9 CFR)

Responsibilities

  • Monitor production and coordinate activities of Laboratory Technicians and operations personnel in inspecting materials.
  • Ensure materials meet specified quality standards.
  • Schedule and maintain QC Technician weekly work schedules.
  • Train employees in SOPs, safety topics, testing procedures, and quality procedures.
  • Monitor QA final acceptance, product Hold, and Materials review.
  • Perform GMP audits of processing areas and write reports.
  • Document and enforce HACCP, GMPs, SSOPs, and SOPs.
  • Perform Raw Material inspections, place on hold if necessary, and submit Supplier Non-Conformance Reports.
  • Prepare product samples for microbiological testing, interpret results, and discuss corrective actions with management.
  • Perform pre-op and in-operational inspections, including ATP and Allergen swabbing.
  • Perform monthly air monitoring testing for facility's freezers.
  • Determine check weigher settings for customer-specific products.
  • Maintain daily Net Content Lot Reports and weekly tare variability reports.
  • Assist Quality Manager in data collection for monthly KPI reports.
  • Work with sanitation to ensure the facility is maintained satisfactorily.
  • Conduct annual Sanitation Validation and report results.
  • Conduct annual validations of pre-requisite programs (Metal Detection, Allergen, Scanner).
  • Maintain supporting documents for Validations (Allergen Matrix, Major Allergen Declarations, Calibration Log).
  • Verify incoming ingredient COAs and Incoming Inspection Reports.
  • Maintain Finished Product, Raw Material, Packaging, Vendor, and Glass and Brittle Plastic Registries.
  • Inspect facility's glass and plastic monthly.
  • Support internal and external audits of the QMS and integrated quality systems.
  • Interact with State, Local, and Third-Party Auditors.
  • Assist Management Staff in special projects or other duties as assigned.

Benefits

  • Responsible for performing within budgeted costs and obtaining specific continuous improvement savings.
  • Execution of job tasks is essential for helping to assure food safety and food quality and prevent the manufacture of adulterated or misbranded products as a result of the availability in the plant(s) of incorrect manufacturing and control information and potentially causing a re-call.
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