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.
Scope of Authority - Oversees microbiological testing for the Horsham facility.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
Sample Collection and Testing = 25%
- 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.
Documentation = 15%
- Complete appropriate documentation to support testing procedures, including data capture forms, equipment logbooks, and inventory forms.
- Identify and troubleshoot equipment problems.
Instrument Maintenance = 5%
- Calibrate and maintain laboratory equipment according to standard operating procedures.
Data Review = 20%
- 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).
Technical Writing = 10%
- Responsible for writing new standard operating procedures or revising existing documentation.
- Prepare validation protocols, executes experiments, and prepares validation reports.
GMP Compliance = 5%
- Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.
- Prepare documentation for presentation to Regulatory Agencies.
Other Tasks = 5%
- 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.
Supervision = 15%
- Supervision of Analysts and their relevant training.
- Supervision of laboratory practices and ensures compliance with relevant procedures.
- Participate in performance reviews of subordinates.
Education & Experience
- 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.
- 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
- 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.
- 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.