Supervisor, QC Microbiology

Employer
Endo International
Location
Horsham, Pennsylvania, US
Salary
Competitive
Posted
May 01, 2021
Closes
Jun 04, 2021
Ref
2153570446
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
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.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Individuals seeking employment are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity record keeping, reporting, and other legal requirements.

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