- Responsible for QC microbiological aspects of cGMP compliance and testing.
- Perform microbiological validations as needed for finished product and in process controls and buffers.
- Serve as SME for one or more of the functional streams: utility monitoring, environmental monitoring or material monitoring.
- Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
- Lead the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Lead the cleaning and process validation activities involving microbiology.
- Lead the investigation of microbiological data deviations and PRs.
- Prepare technical proposals, amendments, reports and memoranda.
- Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation.
- Schedule monitoring procedures with follow-up responsibility to provide test results.
- Review EM and product release data.
- Maintain active communication with other relevant groups including but not limited to Quality Assurance, Manufacturing and Analytical Development.
- Participate in internal assessments and regulatory audits as required.
- Lead training and problem-solving initiatives internally and across site.
- Ensure lab is maintained (organized, clean, properly supplied).
- Evaluate new Microbiology methods and equipment.
- Prepare Quarterly trend reports and other trend reports as required.
- Other duties as assigned.
Required Skills & Abilities:
- Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials.
- Ability to analyze raw data, assess assay and system suitability criteria.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- Good attention to detail and ability to utilize problem solving/trouble shooting skills.
- Good computer skills.
- Demonstrated written and oral communication skills.
- Demonstrated leadership skills.
- Strong organization and analytical skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to lift/pull/push 30 lbs on occasion and 15 lbs regularly.
- Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
- Attendance is mandatory.
- Master’s degree preferably in Biochemistry, Chemistry, Biology or related field with three (3) years of relevant experience; OR
- Bachelor’s degree preferably in Biochemistry, Chemistry, Biology or related field with five (5) years of relevant experience.
- AND 3 years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.