Teva Microbiologist II 

United States, Pennsylvania 

725249567

This position is responsible for performing routine and complex microbiological testing on surfaces, air, compressed gases, steam and purified water and is responsible for interpreting and reporting results. This position is also responsible for monitoring and compiling data for quarterly and yearly reports used to track and trend the EM activities, and preparation of media and reagent. This position will serve as the SME for micro and ensure all activities are performed in compliance with regulatory requirements and company policies and procedures.

• Responsible for performing the environmental monitoring of the designated areas and support facilities during and after production.
• Responsible for collecting, testing, interpreting and reporting results for water, steam, air and compressed gases for micro testing.
• Responsible for performing and qualifying disinfectant studies.
• Responsible for validating microbiology test methods.
• Responsible for trending and various assessments/reports as required, e.g. quarterly and yearly reports.
• Responsible for assuring that required media is available and that the necessary qualifications are met, e.g. growth promotion.
• Responsible for conducting microbial identifications, whether by in-house methods or preparing and sending off-site.
• Responsible for lab organizational/operational set-up and qualification.
• Responsible for supporting validation/qualification activities (process/equipment/facility).
• Responsible for developing, transferring and validating microbiology test methods.
• Responsible for creating and maintaining a library of microbial organisms.
• Responsible for preparing samples for shipment to contract labs as applicable.
• Responsible for drafting/amending Standard Operating Procedures (SOP) for the micro lab as needed.
• Responsible for preparing written reports of investigations as needed.
• Responsible for entering/reviewing data generated by other analyst(s) as needed.
• Responsible for supporting production, validation and quality assurance as needed.
• Responsible for completing training requirements and maintaining compliance with assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s), Work Instructions (WI) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires Bachelor’s of Science degree with a minimum of 3 years relevant progressive experience in a microbiology laboratory with an emphasis on environmental monitoring activities.
• Experience in a manufacturing environment within pharmaceutical, medical device or nutraceutical industries is preferred.
• Understanding of cGMP is strongly preferred.

Skills/Knowledge/Abilities:
• Computer proficiency and working knowledge of MS Office products and systems such as EAM, SAP, Oracle, TrackWise and other computer relational databases.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.
• Interact positively and collaborate with co-workers, management and external partners.
• Communicate effectively with strong written and oral communication and technical writing skills.
• Ability to manage multiple priorities and reporting requirements.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.

Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS: N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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