Job Summary
Responsible and accountable for the leading the site’s Microbiology Laboratory which functions to support the manufacturing of aseptically processed and terminally sterilized pharmaceutical products. Provides technical leadership, daily oversight, and subject matter expertise needed to manage the QC microbiology laboratory functions:
• Microbiological testing of raw materials, in-process materials, and finished products,
• Environmental monitoring and trending of classified rooms/isolators and critical utilities,
• Developing/validating microbiological test methods for bioburden, sterility, and endotoxin.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Provides the necessary microbiological expertise, leadership, and guidance to ensure operations and staff implement appropriate aseptic processing controls, microbial controls, and sterilization controls to meet regulatory requirements.
- Provides microbiological expertise to support product dispositions, investigations, risk analyses, and mitigations related to sterilization, aseptic processing, and micro testing.
- Leads collaboration between functions to maintain and continually improve strategies related to laboratory practices, aseptic processes, and sterilization.
- Supervises, leads, and coaches laboratory staff to ensure all activities are performed and documented according to policies, procedures, and consistent with cGMP and regulatory requirements.
- Accountable to implement the QC micro functions and associated quality system, ensure communication and resource planning, plan and manage budget, and meet regulatory requirements.
- Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
- Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
- Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
- Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.
REQUIREMENTS
- Bachelor's degree in related field; microbiology preferred.
- Minimum 5 years pharmaceutical manufacturing experience; minimum of 5 years of experience in quality management, lab management.
- Experience with high performance teams and development of quality staff is desirable.
- Strong interpersonal skills; must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately.
- Demonstrated business acumen with a proven track record of best practice implementation and accomplishments involving quality, manufacturing, engineering, and warehousing.
- Ability to work both independently and in partnership with others, proven ability to use initiative and drive to achieve results.
- Strong conflict resolution skills.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
