Job Title: QA Specialist

Job Description

The Quality Assurance Specialist plays a pivotal role in ensuring compliance with federal guidelines across all company departments. This position involves enforcing quality policies, practices, and standard operating procedures to maintain adherence to the quality system. The QA Specialist is responsible for monitoring, inspecting, and recommending improvements to enhance product quality and meet established standards.

Responsibilities

• Maintain and oversee quality programs such as HACCP, GMP, Safe Food/Feed, and FSP.
• Coordinate and complete internal and external audits.
• Develop and implement systems to ensure product reliability and compliance with GMP standards.
• Provide guidance to production and lab teams to ensure GMP and GLP compliance.
• Work cross-functionally to assess and address quality needs.
• Ensure all records and documentation meet quality standards.
• Communicate effectively with departments to resolve quality issues.
• Recommend enhancements to fermentation and lab methods, equipment, and product quality.
• Investigate and help resolve quality or regulatory concerns.
• Support the development, implementation, and auditing of quality procedures.
• Conduct monthly scale verifications across facilities.
• Review, approve, and archive batch records for finished products.
• Manage supplier approval programs and raw material testing.
• Assist with updates to batch records, including formula and process changes.
• Compile reports for product development and stability testing.
• Address quality complaints and coordinate resolutions.
• Maintain OSHA and GMP training documentation.
• Support inspections by FDA, regulatory bodies, and commercial partners.
• Assist with quality control procedures as needed.

Essential Skills

• Degree in Microbiology, Biology, or other related scientific fields strongly preferred.
• 2-5 years of QA experience in a food or manufacturing environment.
• Proficiency in GMP, HACCP, GLP, OSHA, and FDA regulations.
• Experience with batch records and raw material testing.
• Audit coordination and completion skills.

Work Environment

The work environment is a small team setting with 30 total employees on-site, working alongside a team of 3 Lab Technicians. The facility operates Monday to Friday from 8:00 AM to 4:30 PM. The QC lab encourages feedback and collaboration to improve team morale and abilities. The environment is independent and requires self-motivation, critical thinking, and time management skills.