• Develop, revise, and maintain SOPs, laboratory methods, specifications, and forms related to raw material testing and control.
• Perform periodic reviews of SOPs, lab methods, specifications, and forms to ensure alignment with regulatory requirements, standards, and internal practices.
• Initiate and manage change controls related to raw material quality documentation.
• Maintain and update calculation worksheets and spreadsheets associated with raw material analytical methods.

• Perform or support analytical testing of incoming raw materials in accordance with approved methods and specifications.
• Review Certificates of Analysis (COAs) and supporting documentation to ensure compliance with material specifications and regulatory requirements.
• Support raw material release, rejection, or conditional approval decisions in accordance with internal procedures.
• Ensure traceability, labeling, and proper disposition of raw materials.

• Conduct laboratory error and out‑of‑specification (OOS) investigations related to raw material testing.
• Identify failure modes, root causes, and corrective and preventive actions (CAPAs) and document findings in clear, defensible written reports.
• Investigate nonconformances, deviations, and process failures impacting raw material quality.
• Execute CAPA activities and verify effectiveness within established timelines.
• Generate deviation reports, nonconformance records, and supporting quality documentation.
• Provide training to laboratory personnel on corrective and preventive actions as required.

• Support laboratory management with data collection, trending, and analysis for raw material quality metrics and QMS objectives.
• Prepare reports summarizing testing trends, supplier performance, laboratory efficiencies, and quality indicators.
• Appropriately archive laboratory and quality system records consistent with retention requirements.

• Provide guidance and training on Quality Systems, quality assurance processes, and laboratory procedures.
• Develop and maintain raw material specifications, testing requirements, and acceptance criteria aligned with ISO, GFSI, and customer requirements.
• Support supplier qualification activities and raw material risk assessments.
• Support internal, customer, and third‑party audits (e.g., FDA, NSF, GFSI).
• Participate on cross‑functional project teams as assigned.
• Perform other duties as assigned.
• Provide internal department communication in regards to raw materials
• Evaluate requalification materials for stock conservsions or extensions
• Creation of raw material COA’s upon request

• Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment
• Strong leadership skills
• Strong knowledge of current quality systems requirements and implementation techniques.
• Superior communication and analytical skills, plus demonstrated skills to handle a variety of assignments simultaneously.
• Customer-advocate to ensure on time task completion.
• Requires excellent written and verbal communications.
• Must have the ability to assess situations and develop solutions
• Must have excellent attention to detail
• Must have the ability to adjust to changing work demands and priorities in a fast paced environment
• Experience with Microsoft Office products with an emphasis on Excel
• Strong analytical experience
• Ability to learn new technologies quickly
• Results driven, strong work ethic
• Strong organizational and time management skills
• Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Must be able to walk, bend, kneel, stoop, climb, reach and grasp for varying periods of time

• Minimum – 4 year university degree
• Preferred – 4 year university degree in science, biotechnology, or other related field.

Experience

• Minimum - 1+ years quality experience in an FDA regulated facility.
• Preferred - Experience in Federal and State Food Safety Regulations including HACCP and GFSI
• Preferred - Experience with food safety and defense programs