Essential Tasks and Responsibilities:

· Review raw material documentation and make disposition decisions

· Assist with training and oversee risk management activities ISO 14971, HACCP, etc.

· Assist with development and review of documents related to regulatory compliance

· Oversee quality auditing (including supplier quality) and assist with review and approval of Batch Production Records and NCMR investigations.

· Support regulatory and customer audits.

· Manage corrective actions as assigned from audits.

· Support and coordinate efforts and priorities with other departments to ensure timely release of the raw material, packaging components and finished products.

· Oversee creation and approval of necessary documentation for out-of-house processing.

· Complaint management including internal investigations.

· Continuous Improvement.

· Review product labels for content, appearance and regulatory compliance.

· Other responsibilities as assigned.

Education & Experience Requirements

· Scientific degree or equivalent strong analytical experience

· Knowledge and experience in good documentation practices

· Understanding of cGMP 21 CFR 111 and other regulatory requirements pertinent to dietary supplements, or pharmaceutical manufacturing and laboratory testing

· Strong preference to experience in TGA or MHRA

Competencies & Qualifications

· Attention to detail and accuracy

· Excellent interpersonal and listening skills

· Strong verbal and written communication skill

· Data analysis and problem solving

· Adaptability and initiative

· English proficiency required

Physical Requirements:

· Employee must exert up to 20 lbs. of force occasionally, and/or up to 10 lbs. of force frequently, and/or a negligible amount of force constantly to move objects

· Specific vision abilities required by this job include close vision, distant vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

· May be exposed to a dusty environment and/or considerable noise

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Layton, UT 84041: Relocate before starting work (Required)

Work Location: In person