Endo International Microbiologist I, Sterility Assurance in Rochester, Michigan

Job Description

Job Title

Microbiologist I


Par Pharmaceutical






Quality / Quality Control Laboratory

Direct Reports (list)


Reports to (title)


Date Submitted


To be completed by Corporate Compensation:

Job Code




Date Reviewed






FLSA (USA only)


Job Summary - a concise overview of the job

The Microbiologist I performs Quality laboratory microbiological analyses of materials including water testing, finished product testing, raw material testing, environmental monitoring, method validation, media preparation etc. Participates in investigations. Learns and stays current with regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Typically supports one Par business, at a single site

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time



% of Time

Microbiology Lab

  • Conducts microbiological analyses: water testing, finished product testing, raw material testing, environmental monitoring, and media preparation

  • Performs day-to-day operations of the Microbiology Lab to ensure that cGMPs, GLPs and all other applicable compendia requirements are met

  • May perform pour plates techniques and pure culture isolation

  • Records results from tests, interprets colony morphology, and accurately maintains laboratory data



  • With guidance, detects and participates in OOS/NOEs and other laboratory investigations

  • May assist in performing microbiological audits of facilities

  • Follows internal processes related to controlled substances



  • Reviews and updates SOPs and procedures for Quality as needed

  • Reviews and comments on the articles affecting Quality in the USP Supplements and Pharmacopeial Forums

  • Oversees maintenance, logbooks, and expiration dates of stock cultures, media, and sterilization documents


Lab Equipment

Maintains laboratory equipment in clean order; reports equipment problems to Supervisor



  • Follows EH&S procedures to ensure a safe work environment

  • Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS





Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • Bachelor of Science degree in microbiology, biology or related field with microbiology coursework required. Some microbiology laboratory experience preferred


Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Proficient with microbiology techniques and instruments

  • Learns regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing

  • Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS

  • Competency in Microsoft Office Suite

  • Knowledgeable in aseptic techniques




Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

  • Ability to display and analyze data in a logical manner

  • Good verbal and written communication skills as well as good computer skills

  • Attention to details and accurate record keeping

  • Ability to establish and maintain cooperative working relationships with others

  • Solid organizational skills

  • Ability to take initiative, set priorities and follow through on assignments

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals

  • Must occasionally lift and/or move up to 15-25 lbs.

  • Ability to wear personal protective equipment, including respirators, gloves, etc.

  • Specific visions abilities are required by this job include close vision and color vision

  • Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods

  • The work environment is representative of a group laboratory environment

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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Endo Job Description Template - Revised July 2014