Microbiologist II (Afternoon Shift)

Quality & Compliance Rochester, Michigan


Description

Job Summary

Perform routine, developmental and validation microbiological quality control testing of pharmaceutical products and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. Conducts and performs deviation investigations and special testing studies of experimental, investigative, validation studies and problem solving nature. Participate in projects to achieve departmental objectives.  Records and reports test results. Notes unusual results and notifies supervision for evaluation.

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-Sterility Assurance

·         Performs routine microbiological testing of raw material, in-process, finished product and stability following approved specifications, and Standard Operating Procedures (SOPs). This may include but is not limited to antibiotic testing, bioburden/microbial limit testing, antimicrobial effectiveness testing, water testing, environmental monitoring, microbial isolation and identification technique, sterility, and endotoxin testing.

·         Completes testing with a high degree of efficiency, reliability, and accuracy.

·         Maintains the Microbiology Laboratory. This may include but is not limited to maintenance, calibration, and use of standard laboratory equipment.

·         Logs samples received into the laboratory and assess their integrity upon receipt.

·         Performs assigned work in timely and safe manner conforming to regulatory, company and compendial requirements.

·         Records and reports test data correctly, completely and accurately within company and departmental policies and guidelines.  Notifies supervision of unusual results for evaluation.

·         Actively assumes and demonstrates responsibility in learning practical laboratory skills, and a thorough knowledge of microbiological theories, methodologies and procedures.

·         Acquires complete knowledge and understanding of company and departmental policies pertaining to cGMP, cGLP, safety, health, security, and departmental operation.  Complies with company and departmental regulations, policies and guidelines in performance of the job.

·         Recognizes problems within scope of job and promptly and clearly communicates them to supervision. Follows directions and demonstrates proper judgment when a deviation occurs.

·         Initiates, writes and approves Laboratory Investigations and Deviations.

·         Reviews OOS and unusual test/equipment data with management or senior staff.

·         Recognizes trends, deviations, problems and promptly reports them to laboratory management. Follows directions and demonstrates proper judgment when a deviation occurs.

·         Participates in inventory control and maintains a neat and orderly workspace, adhering to all laboratory disinfection policies.

·         Conducts and performs experiments related to problem solving for the Microbiology department.

·         Trains less experienced employees on current or new methods or procedures in the lab, under the direction of laboratory management.

 

70%

Compliance

·         Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting

·         Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs

·         Follows internal processes related to controlled substances

15%

Investigations

·      With guidance, participates in OOS/OOT/NOE and other investigations

·      Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action

·      May draft, edit and review SOPs and laboratory investigations

10%

Lab Equipment

·         Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping

·         Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals

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

·         Minimum Bachelor's Degree in Biological sciences (Biology, Microbiology, or closely related field) or equivalent

·         Prefer +2 years of Sterility Assurance / Environmental Monitoring / Microbiology laboratory work experience with increasing responsibilities


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.

·         Thorough knowledge of all basic concepts of Microbiology and awareness of the importance of aseptic technique in performing testing.

·         Must have proficiency in cGMP/GLP practices in a FDA regulated environment 

·         Must have SOP, investigation, and project protocol writing skills

·         Must have good verbal and written communication skills

·         Previous experience with Laboratory Information Management Systems. Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required

·         Must have an understanding of cGMPs, GLP, CFR, ISO and USP

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

·         Establish and maintain cooperative working relationships with others

·         Ability to train less senior staff and develop laboratory skills and ability

·         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.

The physical demands/work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

·         The following are some of the physical demands of the position:

o    Stand

o    Walk

o    Sit

o    Lift

o    Crawl

o    Talk or hear

o    The activities performed daily require physical activity approximately 60-80% of the day

·         This position will require office, laboratory and manufacturing area activities.  These work environments encounter the following:

o    Wet or Humid

o    Work near moving mechanical parts

o    Work in high, precarious places

o    Fumes or airborne particles

 

Wet or Humid

Work

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.