Quality Assurance Specialist - GMP

Description Summary This is a full-time, non-exempt position that is responsible for day-to-day Quality Assurance (QA) activities to ensure continuous manufacturing and production of dietary supplements and dietary (food) ingredients in compliance with FDA Good Manufacturing Practices (GMPs) 21 CFR 111 and 21 CFR 117, Hazard Analysis of Critical Control Points (HACCP), Food Safety and Modernization Act (FSMA), State Department of Health (DOH) and all other applicable regulations, specifications and certifications. Conducts GMP inspections of facilities and equipment, completes process monitoring of critical control points, label reconciliation, process holds, and product release verification. This position assists with management of master manufacturing records, batch records, sanitation records and other GMP records. Supervisory Responsibilities This is not a supervisory position Essential Job Responsibilities Ensures that facilities are sanitary and ready for dietary ingredients and dietary supplement manufacturing processes by conducting pre-operational swabbing and GMP inspections. Conducts HACCP and process monitoring to identify deviations, prevent upsets and product defects. Participates on HACCP and Food Safety Teams to ensure that plans are properly implemented, maintained, verified and that changes are incorporated. Performs daily scale verifications, label reconciliation, release of equipment after maintenance, product return processing, and preparation of Batch Records for product release. Ensures process hold/quarantine of out of specification (OOS) and non-conforming products occurs in a timely manner, product disposition is verified and properly documented. Serves as a liaison with pest control vendor/officer (PCO) and conducts activities in the pest control program, including annual review and evaluation of the vendor. Ensures that pest control activity is monitored between the PCOs service visits. Supports all efforts to ensure compliance with regulatory agencies and standards. This includes GMPs, HACCP, FSMA, DOH regulations and all applicable certifications, non-GMO Project verification, Kosher, Gluten Maintains and updates cGMP Standard Operating Procedures (SOPs), Master Manufacturing Records and Batch Records and ensures that all records are completed correctly, retained, and archived. Supports Document Control System management, provides sales support for customer inquiries, documentation requests, and customer complaint investigations. Organizes and audits GMP records, including but not limited to Non-conforming Product Reports (NCPR), Correction/Prevention Action Reports (CAPA), customer complaints, equipment verification, Batch Records, sanitation and production logs, label revisions, product and ingredient specifications, vendor management, Hazard Analysis and Risk Assessment documentation. Supports new hire and annual training for GMP, Safety, and product certification programs. Support the QC Lab team with sampling and testing as needed. Other Duties Serves as the Scribe in FDA inspections. Identifies improvements to QA processes for greater efficiency and compliance. Performs other duties that may be assigned. Physical Demands This position includes sitting at a computer for extended periods of time, as well as standing at a laboratory bench and walking to other areas of the farm. It may include some occasional lifting up to 40 pounds. Working Conditions Work is primarily performed in an office environment and in manufacturing facilities. Some work in an outdoors setting and laboratory environment as well. Minimum Qualifications Associate or bachelor’s degree or equivalent combination of work experience and education. Previous work experience in food and dietary supplement GMP or SQF environments with good working knowledge of required regulations. Proficiency with PC-based computer applications including Microsoft Word, Excel, and Outlook. Excellent organizational, time management skills, and attention to detail. Preferred current Preventive Control Qualified Individual (PCQI) certification or ASQ Certified HACCP auditor. Strong verbal, written, interpersonal skills, and ability to work effectively on a team. Able to work independently as well as collaboratively on a team. Strong problem-solving and implementation skills. Able to perform the essential functions of the position with or without reasonable accommodation. Management reserves the right to change this job with or without notice. #J-18808-Ljbffr Cyanotech Corporation.