Job Overview:
Overseeing the quality systems and compliance programs for a dietary supplement brand. This role serves as a key quality liaison between the company, contract manufacturers, retailers, distributors, and regulatory partners to drive continuous improvement and maintain compliance with FDA dietary supplement regulations and cGMP requirements. This position requires travel to West Coast division and contract manufacturers
Responsibilities and Duties:
- Quality Assurance Management: Manage and oversee QA staff responsible for inspections and release of finished product.
- Standard Operating Procedures (SOPs): Develop and manage SOPs.
- cGMP Audits: Perform audits of Contract Manufacturers.
- Finished Product Specifications: Approve specifications to ensure compliance with company and regulatory standards.
- Master Formula Review: Review and approve master formulas.
- Stability Program: Manage stability program, including summarizing data.
- Customer Complaint Management: Handle customer complaints, including collaborating with medical professionals on Serious Adverse Event reporting to FDA.
- Product Quality Issues: Investigate and resolve product quality issues.
- Sales and Marketing Support: Assist retail and B2B sales and marketing initiatives as needed.
- Certificates of Analysis: Create customer-facing Certificates of Analysis.
- Product Specifications: Develop product specifications, including attributes for master data, packaging components, and finished product specifications.
- Training Development: Conduct and manage training development with cross-functional teams.
- Label Creation and Updates: Initiate product label creation and updates with Graphic Design team using information from Contract Manufacturers.
- Label/Packaging Compliance: Review and approve product labels/packaging to ensure compliance with 21 CFR Part 101.
- Extended Producer Responsibility (EPR): Oversee and manage the EPR program, staying updated on legislation via the Producer Responsibility Organization (PRO).
Qualifications:
● Bachelor's Degree in Chemistry, Biology, Pharmacy, or a related life sciences field.
● 5 years related experience in a dietary supplement, food, or pharmaceutical environment.
● Strong understanding of FDA GMPs for Dietary Supplements and Food Safety (21 CFR part 111, 117) and DSHEA.
● Experience performing cGMP Audits
● PCQI certification a plus
Skills:
● Ability to prioritize and multitask
● Attention to detail and the ability to manage multiple projects simultaneously.
● Troubleshooting and resolution skills
● Experience with Google Suite and Monday.com a plus
● Ability to work autonomously and independently
● Ability to prioritize multiple projects and tasks
Job Type: Full-time
Pay: $95,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience:
- dietary supplements industry: 5 years (Preferred)
- QA Manager: 5 years (Preferred)
Work Location: In person
