Quality Assurance Specialist

About the role

The Quality Assurance Specialist will oversee all QA controlled documentation and product release related functions. This includes writing and reviewing standard operating procedures (SOPs), reviewing Production Batch Records (PBRs), COAs/COCs, QA inspection documentation, and supporting the NSF Certification Program.

Responsibilities

• Conduct training on quality assurance concepts and tools
• Understand and comply with cGMP regulations
• Support and maintain NSF Certification Program
• Review and interpret analytical and microbiological lab reports
• Coordinate procurement and shipment of product samples
• Perform statistical analysis of finished product results and stability data
• Support and conduct formal procedural inquiries and investigations
• Manage complex tasks individually or as part of a team
• Provide background audit support
• Manage administrative activities related to the QMS (Veeva)

Requirements

• 2-5 years of QA/QC experience in a cGMP environment
• Experience in a manufacturing environment
• A degree in a scientific discipline (Chemistry, Engineering, Physics, Biology, Food Science), preferred
• A robust knowledge of good documentation practices (GDP)
• ASQ, PCQI, or HACCP certification preferred
• Thorough knowledge of regulations for Dietary Supplements manufacturing under 21 CFR Part 111
• Knowledge of GFSI standards and application required
• Strong familiarity with Microsoft suites
• Excellent written and verbal communication skills
• Superior attention to detail and organizational skills
• Ability to work effectively with people and communicate information to obtain positive results
• Comfortable working independently and able to manage time efficiently and adjust to shifting priorities
• Ability to work well under tight deadlines