Teva Senior Microbiologist 

United States, Utah, Salt Lake City 

445832564

This position is responsible for providing reliable and expedient results from the testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities in compliance with all regulatory requirements, company policies and procedures. Additionally, this position will provide training and/or direction to junior analysts and function as a subject matter expert for all aspects of Quality Control Laboratory microbiology testing in compliance with cGMP and SOPs.

• Responsible for scheduling and tracking analysis of incoming materials, intermediates, finished products, swab samples, water samples, environmental monitoring samples, and other samples as needed.
• Responsible for preparing, maintaining, and reviewing thorough records.
• Responsible for conducting investigations and root cause analysis for microbiology related deviations. Support and/or lead laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Responsible for authoring and reviewing microbiological test protocols, technical reports, risk assessments, and validation documents.
• Responsible for performing complex revisions to documentation (including the use of Change Control) such as Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for performing method suitability for compendial methods.
• Responsible for designing and overseeing the execution of complex projects such as method transfers, validations, and regulatory reports.
• Responsible for performing activities associated with the stability program including sampling and statistical analyses.
• Responsible for executing projects of an advanced scope and complexity as assigned.
• Responsible for preparing and providing training to small or large groups and leading meetings as needed.
• Responsible for communicating with multiple departments including manufacturing, planning, and regulatory affairs.
• Responsible for completing all training requirements and maintaining 100% compliance with all 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) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Education/Certification/Experience:
• Requires a Bachelor’s degree, preferably in Microbiology or Biology, or related degree with a minimum of 7 years relevant progressive experience in a Quality Control Laboratory environment.
• Requires working knowledge of cGMP, DEA, and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Prefer experience with Laboratory Information Management Systems (Labware LIMS).
• Prefer some experience with validation activities.
• Prefer experience with nonsterile pharmaceutical microbiology testing: Microbial Limits (MLT), Antimicrobial Effectiveness Testing (AET)

Skills/Knowledge/Abilities:
• Advanced understanding of the principles of microbiology as it applies to sterilization, bioburden testing, media preparation and qualification, aseptic technique, general traditional microbiology laboratory techniques.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), manufacturing/quality systems such as LIMS, and Electronic Document Management Systems (EDMS).
• Ability to effectively plan and document a process, explaining scientific and/or technical ideas using high level technical writing skills.
• Ability to manage multiple priorities and reporting requirements.
• Ability to motivate, influence, and lead others with or without direct supervisory authority.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
• 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.
• Project management and advanced presentation skills.

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.

Visual Acuity:
• Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes. Ability to accurately distinguish colors is required.

WORKING ENVIRONMENT
• Exposure to fumes, odors, dusts, mists or gasses (for non-office).
• Exposure to moving mechanical parts or moving equipment.
• Exposure to low to moderate to loud noise levels.
• Exposure to biohazardous materials.
• May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses, gloves, hearing protection, etc.).

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.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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