Quality Specialist - Hygienist

*3rd shift*

Job Description

We are seeking a dedicated Quality Specialist - Hygienist to join our team. This role involves dynamic daily duties with a focus on environmental quality assurance, requiring significant floor time. The position demands a proactive approach to addressing leaks, pest sightings, and environmental issues on the manufacturing floor, working closely with QA Technicians and Engineers.

Responsibilities

• Respond to leaks, pest sightings, and environmental hits on the manufacturing floor.
• Collaborate closely with QA Technicians to identify investigation points and respond accordingly.
• Conduct GMP audits, including daily assessments and formal walks on the floor.
• Prepare write-ups for environmental incidents, managing 2-3 investigation reports every 30-45 days.
• Participate in SOP writing and documentation.
• Co-own GMP, pest management, leaks, zoning, and other programs alongside QA Engineers.

Essential Skills

• Quality assurance expertise in food manufacturing and GMP environments.
• Experience in the pharmaceutical industry, with skills in PCQI, HACCP, and GMP audits.
• Strong relationship-building capabilities and a coaching mindset.
• Proficiency in environmental site assessment and SOP management.

Additional Skills & Qualifications

• B.S. in Life Sciences with 2+ years of experience in food manufacturing within a GMP environment.
• 2+ years of GMP experience in food, pharmaceutical, biotechnology, or medical device industries.
• PCQI for human food certification is a plus.
• HACCP certification is a plus.
• Experience in hygiene, sanitation, and pre-requisite programs.
• Working knowledge of pathogens, environmental monitoring, cGMPs, and FDA requirements.

Work Environment

The role involves spending 50% of the time on the manufacturing floor and 50% in an office setting. The QA Hygienist works closely with a team consisting of QA Technicians, Engineers, and lab staff, primarily during the night shift. The position offers an engaging environment with opportunities for professional growth and collaboration.