Supervisor, QC Microbiology

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

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.

Qualifications

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.

Knowledge

• 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.

Physical Requirements

• 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.