Quality / Quality Control Laboratory
Direct Reports (list)
Reports to (title)
To be completed by Corporate Compensation:
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
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
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 & 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