Jeff Connolly
Senior Quality Engineer @ Abbott
About
Experienced Quality Assurance leader with a Master of Science in Applied Immunology and Molecular Biology. Passionate about science, quality, technical writing and growing professionally.
United States
Scarborough
Medical Device
Sop, GMP, HACCP, Quality System, FDA, Quality Assurance, Quality Auditing, Food Safety, PowerPoint, Microsoft Word, Microbiology, Validation, Customer Service, Food Industry, Quality Control, Microsoft Excel, SQF, Complaint Management, Change Control, Outlook
Experience

Quality Assurance Manager
Portland, Maine
The Quality Assurance Manager at Oakhurst Dairy is responsible for the development, maintenance, enforcement and integrity of the facility quality and food safety programs. In addition, as a senior level manager, I manage the QA/QC laboratory, work as the lead regulatory compliance officer with State and FDA authorities, am a member of the New Product Development Team (R&D), am a member of the DFA Leadership Council and act as the Environmental Compliance Coordinator. The main goal of the position is to ensure product and process compliance to regulatory, quality and food safety standards for all products manufactured at the dairy. Essential Responsibilities include, but are not limited to: - Direct and manage all facets of the QA Program. This includes writing, training and enforcing QA and Corporate policies related to food safety and quality. - Act as the company liaison with local State and Federal regulatory agencies for three locations. - Lead plant HACCP & SQF teams. - Maintain accurate and current product formulations and manufacturing protocols for all products. - Monitor, through auditing, inspection, sampling and testing - incoming ingredients, processing, packaging and sanitation, to ensure the safety and quality of all finished goods. - Manage, train and direct the QA laboratory personnel to assure accurate and efficient laboratory practices and record keeping. - Accept or reject finished products based on established standards. - Communicate findings and make recommendations to management and corporate personnel. - Audit the plant sanitation programs. - Audit documentation and maintain required records. - Assist in training of all plant personnel regarding good housekeeping, proper sanitation, and product handling. - Work closely with the Plant and Operations Managers and plant personnel to prevent & resolve quality problems. - Assist R & D with in-plant trials.

QA Supervisor
The QA Supervisor oversees the daily workload of the QA Laboratory. In addition, this position directs four full time Lab Technicians. Essential Duties include: - provide guidance and work direction to the QA Technicians. - ensure all laboratory tests are completed on a daily, weekly, monthly and annual basis as required. - enforce quality standards, GMPs and SOPs across the company. - actively uphold, review and enforce the HACCP and SQF plans. - maintain State of Maine laboratory certification for bacteriological and microbiological testing. - maintain an accurate inventory of chemicals and an updated SDS book on file. - review and maintain all laboratory records and documents. - inspect, maintain, calibrate and perform minor repairs on a variety of laboratory equipment and instruments. - maintain a lab work schedule for employees and ensure the necessary coverage requirements are met.

QA Lab Technician
The Quality Assurance Lab Technician position at Oakhurst Dairy is responsible for performing a variety of functions related to testing products for food quality and safety compliance. Essential Duties include: - perform bacteriological, chemical and physical tests on raw and finished goods. - conduct product sampling at various points through the supply chain. - perform microscopy and antibiotic testing on incoming raw milk. - perform packaging evaluations to ensure conformity to standards. - inspect the plant regularly for compliance with Oakhurst Dairy standards and compliance with US public health regulations. - verify cleaning completeness through visual inspection and swabbing activities. - conduct environmental sampling throughout the facility.
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