Supervisor, QC Microbiology

Quality & Compliance Horsham, Pennsylvania


Description

Job Summary - a concise overview of the job

The Supervisor, QC Microbiology will supervise Analysts and help coordinate microbiological testing, release of in-process, intermediates, finished products and testing for validation purposes.  This person will assist in processing data and completing testing forms of the samples examined.

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.

Oversees microbiological testing for the Horsham facility.

 

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

Accountability

Responsibilities

% of Time

Sample Collection and Testing

  • Conduct routine and non-routine analysis of environmental samples, raw materials, in process, and finished products according to standard operating procedures.
  • Adhere to Company safety procedures and guidelines on a daily basis.

25%

Documentation

  • Complete appropriate documentation to support testing procedures, including data capture forms, equipment logbooks, and inventory forms.
  • Identify and troubleshoot equipment problems.

15%

Instrument Maintenance

  • Calibrate and maintain laboratory equipment according to standard operating procedures.

5%

Data Review

  • Review microbiology data for accuracy and compliance with department procedures.  Address any results that do not comply with acceptance criteria or specifications.
  • Write Change Controls, Deviation Investigations (DI’s), Laboratory Assessments (LA’s), and Investigation Reports (IR’s).

20%

Technical Writing

  • Responsible for writing new standard operating procedures or revising existing documentation.
  • Prepare validation protocols, executes experiments, and prepares validation reports.

10%

GMP Compliance

  • Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.
  • Prepare documentation for presentation to Regulatory Agencies.

5%

Other Tasks

  • Apply critical thought to solving problems of complex scope.
  • Work on complex problems requiring an in-depth knowledge of scientific methods and techniques.
  • Act independently to determine methods and procedures on new assignments.

5%

Supervision

  • Supervision of Analysts and their relevant training.
  • Supervision of laboratory practices and ensures compliance with relevant procedures.
  • Participate in performance reviews of subordinates.

15%

Total

100%

 

Qualifications

Education & Experience

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

§  Bachelors of Science in Chemistry, Microbiology, or other relevant field required (M.S. a plus).

§  7+ years’ experience in a pharmaceutical or biotechnology industry with 3+ years in a supervisory role.

§  Microbiology testing experience in a pharmaceutical or biotechnology industry.

§  General experience in a development, quality, or manufacturing environment.


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.

§  Has advanced knowledge of Microbiology

§  Working knowledge in microbiology testing (i.e., USP Purified Water, WFI, Nitrogen, Compressed Air, Environmental Monitoring, bioburden, endotoxin, TOC)

§  General knowledge of cGMP practices, ICH requirements, stability and validation.

§  Has thorough knowledge of, and stays current with, regulatory guidance and compendia relevant to laboratories and pharmaceutical mfg.

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.

§  Acts independently to determine methods and procedures on new assignments.

§  Applies critical thought to solving problems of complex scope.

§  Works on complex problems requiring an in-depth knowledge of scientific methods and techniques.

§  Strong verbal and communication skills required.

§  Proficient in common software applications.

§  Strong technical expertise in a GMP environment

§  Ability to handle multiple priorities in a fast paced environment.

§  Demonstrates excellent interpersonal skills and flexibility.

§  Understanding of basic statistical analysis and familiarity with the use of databases is desirable.

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.

§  Ability to fully gown in an aseptic manner in order to enter, work, and walk in the GMP manufacturing facility.

§  Will have to lift sampling instruments that weighs approximately forty pounds.

§  Travel up to 10 % of the time.