Site Hygienist & Quality

• 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

Qualifications :

• Bachelors degree in Microbiology Biology Chemistry Pharmaceutical Sciences or a related scientific field
• Masters degree is a plus
• 37 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)
  • FDA regulations (21 CFR Parts 210/211)
  • Environmental Monitoring (EM) programs (air surface personnel)
  • Aseptic processing and contamination control strategies
  • CAPA deviation and root cause investigation processes

Additional Information :

SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression genetics status as a protected veteran or any other characteristics protected by law.

To perform this job successfully an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge skills and/or abilities required.

This job description should not be construed as an exhaustive statement of duties responsibilities or requirements but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability please call for assistance and leave a message. You will receive a callback. Please note this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Remote Work :

No

Employment Type :

Contract