Quality Assurance
1 month ago
POSITION SUMMARY:
The Quality Assurance (QA) Supervisor is responsible for: (1) assuring consistent high quality of products through inspection, (2) directing, training, and supervising Quality Assurance (QA) Inspectors/Auditors in their day-to-day activities, (3) maintaining a high quality work environment and partnership between Quality Assurance, Manufacturing Operations and other departments personnel, (4) providing technical assistance to meet established product quality requirements, and (5) supporting the Quality Assurance (QA) Manager in the performance of her/his activities.
The position reports to QA Manager (and/or Vice-President of Quality Systems & Regulatory Compliance Department).
DUTIES & RESPONSIBILITIES:
- Coordinate daily activities of QA Inspectors/Auditors, their work schedules, shift coverage, and time off requests.
- Actively work on the production floor to provide enforce / guidance to QA Inspectors/Auditors, Manufacturing Operations personnel, and all other employees to ensure compliance with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), safety, Standard Operating Procedures (SOPs), good housekeeping practices and all other policies established by Wellington Foods, Inc.
- Report product quality problems or risks to management immediately or take action, if possible, to correct the problem. QA Supervisor is authorized and responsible to stop production when quality discrepancies are discovered.
- Provide guidance and plan of action to QA Inspectors/Auditors, Manufacturing Operations personnel, and other personnel when production events occur and lead investigations of non-compliant issues according to procedures as defined in specific SOPs.
- Collaborate with Manufacturing Operations Department management and supervisory personnel in identifying and resolving problems affecting product quality.
- Initiate Non-Conformance Reports (NCRs) and work with Manufacturing Operations management to ensure that the root cause of non-conformance is determined; corrective action & preventive action (CAPA) is initiated and verify CAPA's effectiveness.
- Conduct routine inspections of plant areas, equipment, and personnel to ensure cGMPs compliance. If discrepancies in cGMPs, procedures, systems or techniques are observed, work with area management to perform root cause analysis, assist in the initiation and investigation of deviations and the development of CAPAs to correct issues.
- Ensure that all non-conforming material and/or product are properly identified, segregated, and reported. Assist in performing “HOLD” and “REJECT” procedures.
- Follow up with implemented programs (cGMPs, GDPs, HACCP, Allergen Control, Organic Certification, Pest Control, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility.
- Review inspection, measuring and testing data collected by QA Inspectors/Auditors to ensure correctness, completeness, and proper documentation.
- Assist in product inspection, testing and measuring as required.
- Coordinate pre-operational sanitation inspection of manufacturing equipment and areas with the Sanitation Supervisor.
- Review batch records and resolve any potential product issues prior to submitting batch records to quality assurance management for product release.
- Coordinate collection of samples for quality control, manage reference samples and reserve samples.
- Coordinate visit of third-party pest control services and manage (along with the Document Control Coordinator) pest control service reports.
- Coordinate the environmental monitoring program: sample collection and submission to Quality Control Laboratory.
- Train QA Inspectors/Auditors for physical inspection of production areas and equipment, components, in-process products, finished products, GDPs, and cGMPs. Responsible for on-time completion of QA Inspectors/Auditors training requirements.
- Assist in performance reviews of QA Inspectors/Auditors regarding the achievement of goals, objectives, and key result areas.
- Maintain a master list of equipment requiring calibration, coordinate third party calibration of specific equipment, and maintain calibration records and schedule.
- Participate in the internal audit program (as required) and may assist with regulatory as well as customer audits.
- Performs other duties as assigned by the Quality Systems & Regulatory Compliance Department management.
- This position includes responsibility for ensuring Food Safety.
- This position may serve as a backup for Food Safety in the absence of key personnel
REQUIRED EDUCATION / EXPERIENCE / SKILLS:
- A high school degree with a minimum of 5 years of work experience as QA Inspector/Auditor including at least 3 years in a lead position.
- A four-year college degree preferably in Food Science or related field (biology, biochemistry, microbiology etc.) with a minimum of 3 years of work experience as Quality Assurance Inspector/Auditor preferred.
- At least 3 years of supervisory or lead experience in a quality assurance role.
- Experience working in manufacturing environment (food, beverage, dietary supplements, nutraceutical, pharmaceutical, biotechnology, personal care), in a quality role with GMP or FDA regulated environment required.
- Good understanding of Good Manufacturing Practices (21 CFR Part 110, 21 CFR Part 111, 21 CFR Part 210), Good Documentation Practices, and Good Housekeeping Practices required.
- Experience using ERP system APTEAN ROSS desired.
- Experience with QMS system Master Control including Mx desired.
- Ability to work under pressure (in an extremely fast paced environment), meet deadlines (overtime work required) and make effective decisions.
- Ability to maintain good, positive working relationship with all personnel. Ability to work with others in a way that elicits their cooperation and support.
- Ability to read and interpret technical documents (for example SOPs), information, and draft routine reports.
- Ability to add, subtract, multiply, and divide all units of measure, using whole number, common fractions, and decimals. Ability to compute ratio and percent.
- Proficient in Microsoft Office (MS Word, MS Excel) and computer-based applications.
- Ability to manage multiple tasks simultaneously.
- Skill in organization and prioritization, and attention to details.
- Strong collaborator and leadership with the ability to work across multiple functions and disciplines
- Must be able to frequently stand and walk on the production floor.
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