Site Hygienist & Quality

SGS•Bowling Green, KY

1d•Onsite

About The Position

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of more than 2,600 offices and laboratories around the world. This role involves driving quality strategy and objectives, leading Good Manufacturing Practices and Risk Assessments, and maintaining training materials for associates in microbiology procedures and hygiene processes. The position requires monitoring quality KPIs, working with operations staff to define quality procedures, and managing pest control processes. It also includes managing customer and supplier complaints, reporting on micro results, developing design solutions, and supporting global audit management. The Site Hygienist & Quality will also manage the quality control lab, develop continuous improvement plans, input requirements for new plant systems, interface with R&D, and lead investigations of out-of-specification results.

Requirements

Bachelor’s degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific field
3–7+ years of experience in a pharmaceutical, biotech, or other GMP-regulated environment
Hands-on experience with microbiological testing, environmental monitoring, and contamination control
Experience supporting FDA inspections and regulatory audits
Proven experience investigating out-of-specification (OOS) or environmental excursions
Experience working in cleanroom or controlled environments
Strong knowledge of: cGMP (Current Good Manufacturing Practices)
Strong knowledge of: FDA regulations (21 CFR Parts 210/211)
Strong knowledge of: Environmental Monitoring (EM) programs (air, surface, personnel)
Strong knowledge of: Aseptic processing and contamination control strategies
Strong knowledge of: CAPA, deviation, and root cause investigation processes

Nice To Haves

Master’s degree is a plus

Responsibilities

Drive quality strategy and objectives for areas of responsibility using appropriate reporting tools.
Lead Good Manufacturing Practices and Risk Assessments, develop corrective actions based on incident investigations.
Attend seminars and keep updated.
Maintain training materials and train associates in microbiology procedures and hygiene processes.
Monitor quality KPIs and report monthly on the status of KPIs.
Work with operations staff to define quality procedures and establish and maintain control and documentation procedures.
Pest control own and manage the overall process and documentation.
Effectively manage customer and supplier complaints and actively monitor supplier quality complaints and issues.
Own reporting, trending, and analysis of micro results and metrics. Take appropriate actions on trends.
Develop and lead design solutions and influence operational solutions.
Develops and maintains the quality strategy in line with KPIs and global initiatives.
Raise awareness of customer requirements across the manufacturing site and lead cross-functional quality improvement teams/projects.
Support global audit management including leading internal audits, and Hygiene audits (system, process, product, customer and external certification audits). Ensure compliance.
Instruct and organize quality training for stakeholders and local quality organization.
Manage the quality control lab, develop continuous improvement plans for the plant and production line.
Input requirements the design of new plant systems. Verify and validate for hygienic design requirements and outcomes.
Interface with R&D and others on new innovation, trials, and analytical method development.
Lead the investigation of out of specification microbiological and related results. Culture and identify microorganisms and lead corrective action development.