Responsibilities
- Execute day-to-day QA GMP compliance activities to protect the brand while driving growth ambition, including product release, artwork review, creating, reviewing, and/or approving specifications, trending data and creating monthly and quarterly reports
- Document Management
- Updating documentation in Veeva QualityOne
- Support Change Control program
- Executing training program administrative duties
- Supporting other quality programs as needed such as NCR/deviation/out of specification program and other projects as assigned
- Partner with external stakeholders, such as manufacturers and testing laboratories, and internal partners such as Formulation, Product Development, Supply Chain, and RA, to ensure timely QA deliverables, working as an effective member of cross-functional product teams
- Work with internal and external companies to ensure appropriate QA deadlines are being met to ensure end to end regulatory compliance for the business
- Participate as an effective member of cross-functional product teams
- Assist with additional quality projects/tasks
Requirements
- Bachelorβs degree in quality assurance, biology, chemistry, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job
- 5+ years of direct US dietary supplement/Consumer Healthcare Quality experience
- Knowledge of product stability programs and laboratory testing preferred
- Knowledge and experience on FDA and applicable laws and regulations, as well as of cGMP standards
- Hands-on experience executing QA GMP compliance for a broad portfolio of dietary supplements or related products
- Applied technical knowledge to ensure GMP standards are met throughout the product life cycle
- Effective prioritization skills and the ability to execute on multiple projects, collaboratively and independently, in an agile environment
- Proven ability to communicate and collaborate effectively with a variety of audiences, both internal and external
- Strong analytical, organization and critical thinking skills
Preferred
- Dietary Supplement category experience
