Microbiologist I

Quality & Compliance Rochester, Michigan


Description

The Microbiologist I performs Quality laboratory microbiological analyses of materials including water testing, finished product testing, raw material testing, environmental monitoring, etc. using aseptic technique.   Initiates and 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

Accountability

Responsibilities

% of Time

Microbiology Lab

§  Conducts microbiological analyses: water testing, finished product testing, raw material testing, environmental monitoring

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

§  Records results from tests and accurately maintains laboratory data

§  Participates in required cleaning of the laboratory

80%

Compliance

§  With guidance, detects and initiates laboratory investigations

§  Follows internal processes related to controlled substances

5%

SOPs

§  Reviews and follows SOPs and procedures for Quality

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

10%

Lab Equipment

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

5%

Safety

§  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

Continuous

Total

100%

 

Qualifications

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


Knowledge

Proficiency in a body of information required for the job   

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

§  Understanding of 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, LIMs

§  Knowledgeable in aseptic techniques

Skills

&

Abilities

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

§  Ability to adapt to a changing work environment.

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.  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.