- Provide technical support to daily operations in Microbiology Lab with safety, quality and operational excellence mindset. Maintains quality systems and procedures in compliance with regulatory expectations. Support results releases, method transfer, verification, or validation activities.
- Ensure drug products is tested in accordance with highest standards of Good Manufacturing Practice (GMP), ICH guidelines, and according to regulatory guidelines, laws and Standard Operating Procedures (SOPs).
- Ensures that Standard Operation Procedures (SOP) are current and in compliance with regulatory and corporate standards. Monitor laboratory compliance data and look for trends.
- Manage Lab investigations and change controls. Identify opportunities to reduce investigations and focus on continuous improvement.
- Active participate in laboratory process team.
- Participates actively of internal/external audits to the area. Support Self Inspection Program and Audit readiness.
- Participates in self-assessments as Lead auditor or team member.
- Provide guidance in regard to changes being proposed to laboratory systems/processes as part of projects or any other initiative.
- Mentor Lab Analysts in quality and safety aspects for the Lab.
- Participate in global QC forums related to compliance and/or quality control.
- BS or MS degree in Microbiology or Biology. PhD in Microbiology or Biology is preferred.
- 5+ years of relevant industry experience in Micro Laboratories
- An excellent understanding and knowledge of Micro techniques, USP compendial test methods, ICH guidelines, and good manufacturing practices.
- Experience working in a pharmaceutical GMP manufacturing environment.
- Demonstrated strong scientific and technical knowledge in microbiological analyses.
- Bilingual (English/Spanish)
- Strong communication skills and the ability to collaborate with other parts of the organization and across multiple levels are essential.
- Computer literate
- Teamwork oriented
- Compliance mindset and sound judgement
- Able to work under minimum supervision.
- Flexibility is required to provide technical support and continuity to a 24/7 process operation.
Sr. Biologist-Microbiologist - San Juan, Puerto Rico - Lilly
Descripción
We're looking for people who are determined to make life better for people around the world.
Position Summary:
Roles and Responsibilities:
Required Qualifications:
Additional Preferences :
Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.
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