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QA Regulatory Manager - Vancouver, WA

Columbia Nutritional

$60,000 a year

 

 

 

 

Major Duties and Responsibilities:

  • Assure that customer specifications are achieved, and the facilities meets local, state and federal food safety and health regulations
  • Provides leadership and management to the Quality Assurance technical and product testing staff.
  • Develops, implements and maintains QA and facility policies, procedures, and programs supporting food safety and quality systems with a focus on specific customer requirements.
  • Assures that QA team is properly trained in food safety, quality systems and testing methodologies.
  • Reviews and recommends approvals for deviations, holds, rework, and in-process adjustments and investigates non-conformances, and deviations as needed. Oversee raw material component review of inspection, control and release
  • Authorizes final product release for components, raw materials, labels, bulk and finished goods.
  • Ensure that all incoming product and finished goods meet specifications and compliance (FDA, USP, NF, Health Canada, etc).
  • Manage finished goods hold and release program.
  • Manage label process in accordance with 21 CFR part 111 ensuring compliance with all regulations and requirements, as applicable.
  • Act as a safety and regulatory/compliance subject matter expert for vitamins, dietary supplements, and nutrition products
  • Manage final review and approval of Master Batch Records, Manufacturing Batch Records, SOPs, Change Control Documentation, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, and Supplier Qualifications.
  • Prepares and handles second party audits (customer) and third party food safety audits; Responsible for FDA or regulatory audits and responses.
  • Coordinate with Manufacturing to make certain that products will meet quality and regulatory requirements, and that processes are efficient and effective.
  • Monitor, review and track internal customer complaints and assist in the prompt resolution of quality issues. Prepare reports by collecting, analyzing, trending and summarizing deviations.
  • Adverse Event process and response
  • Other duties and/or responsibilities as requested or assigned.*Basic Qualifications

*

  • Bachelorís Degree in food science, nutrition, microbiology or related field.
  • Five to ten years of regulatory, manufacturing and/or auditing experience with vitamins, dietary supplements, and nutrition products.
  • Exceptional risk assessment skills (regulatory requirements, safety and quality risks).
  • Self-motivated with critical attention to detail, deadlines and reporting.Essential Skills:
  • Strong leadership, team building, motivator, ability to prioritize, decisiveness, and administrative skills required.
  • Excellent verbal and written communication skills with good computer skills. ERP experience a plus.

Job Type: Full-time

Salary: $60,000.00 /year

Experience:

  • Manufacturing auditing: 5 years (Required)
  • Regulatory Compliance: 5 years (Required)

Education:

  • Bachelor's (Required)

Work authorization:

  • United States (Required)

 

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