Job Description Summary
Managing and coordinating Microbiological testing of raw materials, In-process materials, finished products, stability samples for various Microbiological testing's like MLT, Water, Culture Maintenance, BET, Particulate Matter Testing, Sterility, AET and Container Closure Integrity Testing.
Ensuring compliance with standard operating procedures (SOPs), Test methods and various regulatory guidelines.
Job Description
1. Oversight of Microbiological Testing:
- Managing and coordinating Microbiological Testing of raw materials, In-process materials, finished products, stability samples for various Microbiological testing's like MLT, Water, Culture Maintenance, BET, Particulate Matter Testing, Sterility, AET and Container Closure Integrity Testing.
- Ensuring compliance with standard operating procedures (SOPs), Test methods and various regulatory guidelines.
2. Personnel Management:
- Planning and work allocation for Microbiology laboratory analyst's and Sr. analyst's for timely execution of various Microbiological testing and associated laboratory operations.
- Troubleshooting and problem solving in case of any difficulties during day-to-day lab operations and testing's.
- Ensure for adherence to various Schedules related to calibrations, Preventive maintenance, Requalification's of various Microbiology laboratory instrument's/equipment.
- Training and Qualification of Microbiology analysts/Sr. analysts on various laboratory operations/ techniques.
3. Quality Governance and Assurance.
- Developing and reviewing SOPs, protocols, validation reports, trends and test methods in accordance with internal Endo quality policies and regulatory guidelines.
4. Interdepartmental Collaboration:
- Working closely with cross functional teams (CFT's) such as QA, Manufacturing, QC, Warehouse to support product development and production.
- To attend the meetings for insights and deliverables associated to Microbiology and plan the action plan according to business goals.
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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