Microbiologist II (Sun - Wed Shift)

Quality & Compliance Rochester, Michigan


Description

Job Description

 

Job Title

Microbiologist II

Company

Par Pharmaceutical

Function

Quality

Location(s)

Various

Department

Quality / Quality Control Laboratory

Direct Reports (list)

n/a

Reports to (title)

Various

Date Submitted

 

 

Job Summary - a concise overview of the job

The Microbiologist II performs Quality laboratory microbiological analyses of materials including water testing, finished product testing, raw material testing, and method validationSupports laboratory investigations of moderate scope and complexity while abiding by GMPs and GLPs.  Has working knowledge of, 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, media preparation, method verification and validation, and identification of microorganisms
  • Performs day-to-day operations of the Microbiology Lab to ensure that cGMPs, GLP’s and all other applicable compendia requirements are met  
  • Schedules monitoring and samples for testing/inspection, reviews data and ensures monitoring, testing, and inspection is completed per approved procedures
  • Reviews test data and ensures testing is performed based on approved procedures
  • May review testing/inspection results and disposition incoming/in process/finished product
  • May perform pour plates techniques, membrane filtration, and pure culture isolation
  • Records results from tests, interprets colony morphology, and accurately maintains laboratory data
  • Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends corrective actions

65%

SOPs

  • Validates/qualifies test procedures and equipment used for various testing/inspection activities performed by Quality
  • 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

15%

Compliance & Investigations

  • May perform gap assessments for procedures for the various Quality programs (EM, incoming/in process/ finished product Inspection, component/raw material/product review and disposition) to ensure cGMP compliance
  • Supports laboratory investigations of moderate scope and complexity while abiding by GMPs and GLPs 
  • Assists in performing microbiological audits of facilities
  • Follows internal processes related to controlled substances

10%

Lab Equipment

  • Maintains laboratory equipment in clean order; reports equipment problems to Supervisor
  • Performs laboratory equipment qualifications
  • Learns to troubleshoot basic instrument problems

5%

Training

  • Demonstrates responsibility in training others in good documentation practice, practical lab skills, and microbiological theories, methodologies and procedures
  • Maintains assigned training records current and in-compliance

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 2+ years’ relevant microbiology laboratory experience OR
  • Master of Science degree in above disciplines with 1+ year’ relevant pharmaceutical lab 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.

  • Demonstrated proficiency with microbiology techniques and instruments
  • Demonstrated competence in conducting microbiological analyses
  • Knowledge of 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

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

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