Supervisor, QC Microbiology
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
% of Time
Sample Collection and Testing
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.
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.
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 & 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.