Job Description
This Quality Assurance Specialist position reports to the Quality Assurance Manager and provides support for daily QA/QC activities as required. The position will complete activities within the QA/QC department to ensure all facilities and suppliers are cGMP compliant. This position will assist with retailer communications, product release, and general QA processes as needed.
JOB FUNCTION AND DUTIES
Core duties and responsibilities include the following (Other duties may be assigned):
- Under applicable GMPs within the Quality System collaborate with Quality, R&D, Business Development and Supply Chain
- Conduct product quality complaint investigations and root-cause analysis for manufacturing deviations
- Lang Representative for Third Party audits conducted at our Contract Manufacturing and Packaging sites (DOMESTIC TRAVEL REQUIRED)
- Conduct Vendor Qualification including reaching out to external raw material suppliers, contract manufacturing or packaging facilities including Vendor / Supplier Audits and Audit Reviews
- Maintain product information in retailer specific online portals as needed
- Creating and Routing Organoleptic Approval Forms
- Lead Internal Auditing
- Lead Mock Recall
- Support Investigation (CAPA) / Deviations, Change Controls & Inspection Protocols
- Maintain metrics dashboard for Third party audits or vendor qualifications
- Maintains a working knowledge of the latest regulations and relevant codes to aid in the auditing process
- Compiles and Reviews QA documentation for internal and external purposes
- Works collaboratively across departments to understand critical dates and tasks
KNOWLEDGE, SKILLS & ABILITIES (KSA)
- Dietary supplement / health care industry experience
- Extensive/thorough knowledge of 21 CFR Part 111 and cGMPs
- Contract manufacturer audits
- Highly organized and disciplined in handling communications and documentation
- Efficient with multi-tasking
- Strong attention to detail
- Good technical and quantitative skills
- Excellent writing and communication skills
- Proficient with MS Excel, MS Word, and Outlook. Teams, Adobe, and OneNote a plus.
- Understanding of database management and project management a plus
- Speak and write clearly and persuasively in positive or negative situations
- Works well in a team environment
- Self- driven, motivated, with a flexible attitude
- Adapts well and quickly to change
EDUCATION
Bachelor's Degree + 2-4 years of experience in dietary supplements or healthcare industries
Company Description
We are an innovative health benefit-driven dietary supplements manufacturing company located in Newport, RI. Established in 1984, Lang Pharma Nutrition is a full service, mass market private label and corporate brand manufacturer. We specialize in delivering turn key products, featuring exclusive and innovative materials across a broad spectrum of delivery system and packaging formats. We leverage a global network to continually track emerging ingredients, technology, intellectual property and science in order to identify, and quickly bring to the retail shelf, tomorrow’s market leading products which will meaningfully impact human health through nutrition. We service the largest retailers in the country continuously bringing them new products with superior ingredients.