Daniel Waruszewski Email & Phone Number

Pittsburgh

Responsible for the maintenance of high-quality pharma-related products. Manage eight Quality Assurance staff members for performance of daily duties including line-clearance prior to start-up on-line resting, and finished product specification compliance.Participate in continuous improvement of Production and Packaging according to FDA standards, enforce adherence to all applicable OSHA and EPA regulations and assure NSF and FDA compliance.Responsible for pest control compliance, calibration of metal detection equipment and scales, and approval of new equipment for sanitary design. Assure environmental temperatures of storage areas are within specified parameters.Approve work orders prior to production and batch records after production. Initiate Hold process and facilitate resulting Deviation Report process. Monitor GDP (Good Documentation Practices and issue monthly updates on progress.Perform twice-daily walk-throughs of facility.Co-lead weekly Safety meetings.Conduct weekly QA meeting with QA staff.Meet weekly with Packing management (Complaints, GMP’s, other concerns) Participate in weekly Release to Commerce Meeting and Holds Management Meeting to address substandard material. Present portion of Quality Metrics at monthly Executive meeting. Create and revise Standard Operations Procedures (SOP’s) as necessary. Manage and promote professional growth of Quality Assurance staff.

Pittsburgh Pa

Manage three Quality Assurance staff members for performance of daily duties including pre-op inspections, daily GMP audits, daily product-in-process audits, finished product evaluations, raw material inspections, allergen swabbing , label inspections, internal temperature monitoring, testing procedures, environmental Listeria swabbing.Perform daily review of production records (critical control points , net weights , metal detection, labeling compliance); of warehouse incoming and outgoing shipping records (temperatures of shipper and product, cleanliness); and of electronic data showing temperatures of refrigerated storage areas(assuring that temperatures do not exceed 41 degrees F and enforcing emergency procedures if temperature exceeds requirement.)As HACCP facilitator, created and maintain 17 HACCP Plans that represent all varieties in product profile.Identify and issue Corrective Actions when deviations to HACCP Plans or Quality Programs occur. Follow through and verify resolution and preventive actions occur. Conduct weekly HACCP/Quality Meetings with heads of all departments in attendance to address any concerns affecting Food Safety or Food Quality and future plans. Act as liaison to government regulatory inspectors (USDA, FDA, PA Department of Agriculture); to outside Sanitation Chemical Technician, and to outside Pest Control Operator. Meet and discuss all concerns and determine action plans.Facilitate monthly GMP audit and Glass and Brittle Plastic audit to address all areas of the facility meet requirements, Present unacceptable results to respective department heads and to team at Weekly HACCP/Quality Meeting.Administer Food Safety Training for new employees and annual refresher training for all employees. Topics include GMP, Allergens, HACCP, Listeria, Sanitation, and Food Defense.Act as liaison to government regulatory inspectors (USDA, FDA, PA Department of Agriculture).

Pittsburgh Pa

Responsible for quality audits of co-packers, ingredient and packaging vendors, and warehouses and for label line audits of 3 internal facilities. Managed documentation for 2 canneries and 1 co-packer. Led staff of 2.Audited potential and approved co-packers, ingredient and packaging vendors, and warehouses. Evaluated up to 8 external facilities per year using criteria based on established programs (HACCP, SQF, GMP). Generated audit reports and provided recommendation of approval or rejection of outside partner. Led semi-annual label line audits in 3 internal facilities. Observed performance of line operators to assure adherence to standards. Inspected product to assure accuracy of labeling. Produced audit reports presenting strengths and identified weaknesses for further improvement.Managed documentation for soup and infant feeding production and quality systems. Maintained 750 active documents and created 200 new documents. Collaborated with operations, quality, regulatory compliance, packaging, thermal process, and R&D to assure document accuracy. Represented quality systems at weekly reformulation meeting including marketing, planning, regulatory compliance, and R&D.Created and maintained 3 audit forms (warehouse, vendor, and co-pack) that incorporated food safety and food security parameters.Initiated risk assessment for 600 ingredients evaluating kosher status, allergens, packaging, microbiological vulnerability, additives/preservatives shelf-life, and storage. Participated on team to assure British Retail Consortium (BRC) certification. Revived and facilitated commissioning process meetings for new and reformulated products with participation from operations, quality, and R&D.Facilitated quality and operations documentation transfer after purchase of soup and infant feeding varieties from Del Monte.Trained and led temporary staff to maintain, create, and revise quality documents.

Pittsburgh Pa

Responsible for management of production and quality systems documentation, ingredient specifications, and vendor approval for 2 canneries and 2 co-packers in the U.S. Led staff of 1.Ensured documentation for soup and infant feeding production and quality systems. Maintained 600 active documents and created 150 new documents. Assisted StarKist tuna division in emulating documentation and obtaining label proofs.Managed ingredient specifications for soup and infant feeding. Maintained 1,000 ingredient specifications and created 75 new ingredient specifications.Obtained 1,250 packets of current supplier documentation for all ingredients from approved vendors, and automated information retrieval to improve access.Drove new vendor approval process for 75 new vendors. Requested and evaluated documentation. Conferred with R&D to discuss findings and next steps.Facilitated quality and operations documentation transfer after purchase of soup and infant feeding varieties from Heinz.Trained and managed Documentation Specialist.

Pittsburgh Pa

Responsible for management of production and quality systems documentation, ingredient specifications, finished product specifications, and vendor approval for 5 canneries in the U.S.Managed development and maintenance of ingredient specifications, process sheets, and finished product specifications. Participated in e-commerce process to assure quality ingredients at competitive prices. Led approval of alternate suppliers. Oversaw and documented kosher and allergen status of 1,000 ingredients. Participated in ingredient improvement teams. Initiated and expedited approval process for key quality documents.Responsible for auditing vendors (up to 25 per year), co-packers (up to 10), and potential acquisitions (up to 5 per year) in the U.S. Developed and maintained co-pack manuals and ingredient specifications.Responsible for auditing suppliers (up to 25 per year) and 5 canneries in the U.S. Developed and maintained ingredient and processing specifications for over 1,000 ingredients. Developed and maintained process sheets (bill of material, quality standards, manufacturing instructions, packaging, processing, and revisions). Conducted supplier quality audits and participated in quality systems audits of factory operations to assure compliance with GMP’s of FDA. Held positions as Sr. Quality Audit Technologist and Sr. Microbiologist

North East, Pa

Managed a staff of 10 technicians in assuring the quality of fruit juices and fruit concentrates from incoming ingredients and packaging to finished product. Worked at this position until December 1982. After economic lay-off. I obtained positions as contract QA technician in Erie area due to terminal illness in immediate family.

Fulton, Ny

Managed a staff of 6 technicians in assuring the microbiological quality of chocolate and chocolate related products from ingredients to finished product.

Master Of Public Health (Mph), Microbiology

Master Of Science (Ms), Microbiology/Molecular Biology

Bachelor Of Science (Bs), Biology