Florida, Tampa-St. Petersburg-Cl
Essential Roles and Responsibilities include the following: (other duties may be assigned)
1. Act as liaison between customer, external laboratory, process authority and regulatory compliance.
2. Approve ingredients, components, labels and packaging materials for use in production.
3. Approve material specifications for ingredients based on customer supplied specifications and product label claims for identity, strength, purity, microbiological and limits.
4. Approve product for release based on production record review, HACCP compliance, micro, chemical and analytical test results.
5. Approve qualifying contract labs based on confirmation of accreditations, certifications (ISO 17025) and Quality Lab Agreements.
6. Approve supplier/material documentation.
7. Assist in non-conformance report preparation of Quality System observations from internal plant audits.
8. Assist in the development of internal procedures and forms as needed to perform different activities related to quality, food safety and manufacturing operations.
9. Calibrate and maintain laboratory equipment.
10. Collect, prepare, pack and ship product and ingredient samples as required for testing and review.
11. Collect, store and reserve representative samples for retention.
12. Compose analytical data reports for internal and external evaluation.
13. Develop and issue product specifications, MMR, MBR based on customer specifications.
14. Develop Certificate of Analysis for approved products.
15. Develop product specification based on customer provided documentation.
16. Disposition materials and product by authorizing as approved, rejected, quarantined and released.
17. Evaluate supplier qualification data.
18. Inspect purchased and pre-purchased ingredients, components, labels and packaging materials for adherence to specifications.
19. Interpret analytical test results including chemical and microbiological parameters.
20. Investigate OOS observations, deviations and non-compliant results from production records, customers and suppliers.
21. Maintain and/or establish quality system documentation by developing, updating and implementing forms, logs and records.
22. Maintain internal quality records for incoming materials and finished product.
23. Monitor regulatory compliance for HACCP, GMP and product certifications by reviewing in-process batch records.
24. Observe blending, filling, packaging, rework and disposal operations.
25. Perform quality analysis on batch samples, finished products and other materials as designated.
26. Prepare and issue production records necessary for operations by following manufacturing instruction, product formula and product specifications.
27. Record production data on computer database for recordkeeping and traceability.
28. Replenish analytical reagents and lab supplies and maintain clean work area.
29. Review all receiving records for ingredients, components, labels and packaging material for conformance to documentation and recordkeeping practices.
30. Review and approve 3rd party test methods and results.
31. Review product formulation for regulatory compliance including ingredient label claims, product certifications, allergens, serving size, product volume and category.
32. Review product label claims to customer specification and analytical test results for product release.
33. Review production batch records for good recordkeeping practices including: document errors, proper sign-off, legibility, correct form revision, OOS results, deviations, and non-conforming/incomplete data.
34. Support compliance activities associated with the Quality Management System including but not limited to the following: SQF Program, Good Manufacturing Practices, HACCP Principles and Standard Operating Procedures.
35. Track and trend analytical data for quality management system.
36. Verify sanitation program effectiveness by conducting environmental testing and sampling.
37. Weigh ingredients for blending batch preparation based on master manufacturing record.
: Demonstrate the ability to function independently and productively and display investigative orientation with independence for design of new and existing customer projects
: Must have strong commitment as well as a contribution to long-term strategic development of a project or function area
: Able to organize and provide written and/or oral presentations of work with minimal input from others. Operates with a sense of urgency and consistently demonstrates the ability to prioritize workload.
Education and Experience
: Bachelor' s Science Degree OR Associates Degree and at least Two (2) years of experience in a similar role.
: One (1) to three (3) years related experience with FDA regulations including Good Manufacturing Practices and Good Laboratory Practices.
: One (1) to three (3) years related experience in technical and or scientific document review.
: Food safety training in at least one (1) of the following: HACCP Training, HACCP Certified, Serve Safe or Food Safety Manager.
: Previous experience in food and beverage manufacturing, food safety, facility inspections, quality control or regulatory compliance.
: Experience with FDA regulations including Food Safety Modernization Act (FSMA), Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
: Experience with Global Food Safety Initiative (GFSI) benchmark schemes including SQF.