• Develop, revise, and prepare SOPs, laboratory methods, and forms to support lab operations.
• Conduct periodic reviews of SOPs, Lab Methods, and Forms to ensure compliance with current regulations, standards, and internal practices. Submit change controls as needed.
• Maintain and update calculation worksheets associated with laboratory methods, where applicable.

• Ensure laboratory equipment is properly validated or verified and maintained in a validated state.
• Ensure laboratory methods are validated or verified according to requirements and kept current.
• Assess, develop, and execute validations and qualifications for laboratory methods, processes, and equipment.
• Review and approve laboratory notebooks, validation protocols, reports, technical specifications, and spreadsheet validations.
• Maintenance & Calibrations
• Establish and maintain calibration protocols and maintenance records in compliance with cGMP, cGLP, and relevant regulatory standards.
• Schedule and coordinate calibration activities to ensure equipment remains within calibration due dates.
• Oversee equipment maintenance and repairs, including management of third-party service providers.
• Manage all equipment, calibration, and maintenance records according to internal procedures.
• Ensure proper use and documentation of maintenance logs.

• Conduct Laboratory Error Investigations, identifying failure modes, root causes, and corrective/preventive actions (CAPAs), and prepare clear written summaries.
• Perform investigations into non-conformances and process/equipment deviations with appropriate root-cause analysis and CAPA documentation.
• Execute CAPA investigations and ensure timely implementation and verification.
• Create deviation reports, nonconformance documentation, and related quality system records.
• Provide training to laboratory personnel on corrective and preventive actions as needed.

• Support Lab Management with data gathering and trending for Quality Objectives, QMS metrics, and other quality system indicators.
• Prepare and present reports summarizing departmental activities, trends, and efficiencies.
• Assist with organizing, filing, and archiving laboratory documents and data.

• Deliver guidance and training on Quality Systems, Quality Assurance processes, and related procedures.
• Develop specifications for laboratory reagents, supplies, and materials in alignment with ISO standards.
• Coordinate stability studies and manage reporting of results.
• Support internal and external audits
• Serve as a participant on project teams as assigned.
• Act as a delegate for Lab Administration and Quality Assurance Specialists when needed.
• Perform other duties as assigned.

• 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.

• 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

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