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Supervisor, QC Microbiology

Employer
Endo International plc
Location
Horsham, Pennsylvania, US
Salary
Competitive
Closing date
Jan 26, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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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.


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.
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