DescriptionOversees quality systems related to analytical and microbiological evaluations of inventory for conformance to specifications and regulatory requirements. Works closely with R&D, Sales and Customers to ensure new and existing product specifications and test methods are appropriate, relevant, and testable. Lead, manage and maintain the ANS stability program for expiration dating and retention stability. Manage Lab Services' team of lab testing coordinators and the lab sample flow system from receipt of materials to release including outside contract lab testing. Coordinate with Sales, Production, Planning, and Purchasing to ensure all necessary testing is performed within given timeframes, relaying prioritization and other information to lab members.
Requirements- Follow all company policies and procedures.
- Follow and ensure compliance of quality systems and cGMP programs.
- Works with R&D, Sales and Customers to define and establish appropriate specifications and test methods for new products and as needed, raw materials.
- Serves as an advisor to Laboratory Services in the setting or revising of product specifications and test methods. Reviews and approves new products and revisions to existing specifications.
- Respond to company, customer, regulatory, and vendor inquiries regarding analytical or microbiological methods, results, and interpretations.
- Recommends changes to formulations to provide assurance that products will meet specifications throughout their expected shelf life.
- Reviews results of stability testing and recommends appropriate shelf-life periods or changes in formulation to prolong shelf life.
- Approve final stability study reports summarize data for customers.
- Manage OOS programs related to stability and release criteria samples.
- Reviews and dispositions of Laboratory Services OOS investigations.
- Creation of Lab Services Disposition sheets for finished products based on formula review, customer feedback, ANS SOP, and industry standards. This includes specifications for label claims, micros, heavy metals, and other customer requirements.
- Complete heavy metal theoretical calculations based on product formula and trending results.
- Assist is raw material specification development (i.e. Specification Sheet Creation, Test Data Sheet Creation, Acceptable Recovery Calculations, TraceGains data management, etc.).
- Support sales in new product setup by managing NPI / RMI trackers.
Additional- Perform other duties as assigned or needed.
- Reports to Senior Manager of Lab Services.
- Responsibility: Ensure compliance with Good Manufacturing Practices (GMPs) and monitor all Critical Control Point (CCP) according to the HACCP plan.
- Authority: To stop production lines or place product on "Quality Hold" if food safety risk, sanitation failure, or deviation from critical limits is identified.
- Reporting Authority: Must immediately report any food safety non-conformance or equipment malfunction that threatens product integrity to the SQF Practitioner or QC Manager.
Credentials/Knowledge- Supervisory role of direct and indirect reports.
- Must have a college degree in scientific discipline, or equivalent work experience
- Five years of relevant work experience.
- No certifications or licenses required.
- Must have complex math skills.
- Complex reading skills required.
- Complex computer skills needed.
- Must have complex language skills.
- Must have complex writing skills.
- Must be willing to learn new tasks and procedures.
- Ability to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to self or others.
- Maintain a regular and dependable work attendance record with few instances of unplanned and/or unexpected absence.
Typical Environmental ConditionsOffice and Lab conditions include:
- Temperature variations may occur throughout the day.
- Exposure to food ingredients, including food allergens, in free-floating powder form.
- Exposure to chemicals, microorganisms, fumes (including autoclaved materials) and airborne particles.
- Lab noise may include vacuum pumps, sonic baths, instrumentation, chillers, stability chambers, refrigerators, autoclaves, tapped density, and other equipment.
- Protective equipment such as safety glasses, lab coats, respirators, gloves, hearing protection, masks, back belts, or cGMP attire suits may be required or recommended in certain situations.
Production Area includes these environmental conditions:
- Exposure to food ingredients, including food allergens, in free-floating powder form.
- Moving mechanical parts, vibrations, and risk of electrical shock.
- Noise levels are usually moderate and often constant.
- Protective equipment such as gloves, hearing protection, masks, back belts, or cGMP attire suits may be required or recommended in certain situations.
