QC Analyst l - Microbiology

Employer
Endo Pharmaceuticals
Location
Horsham, Pennsylvania, US
Salary
Competitive
Posted
May 08, 2021
Closes
May 26, 2021
Ref
2143372533
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Description
Job Summary - a concise overview of the job

The QC Analyst I - Microbiology will perform microbiological testing, release of in-process, intermediates and finished products, and testing for validation purposes. This role completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms. Additionally, this role is responsible for assisting with the writing of standard operating procedures (SOPs) and revision of existing documentation.

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.

Quality Control (QC) Microbiology Department.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Sample Collection & Testing

§ Conducts routine and non-routine analysis of environmental samples, raw materials, in process, and finished products according to SOPs.

§ Reports identified abnormalities to QC Management for resolution and response.

§ Adheres to Company safety procedures and guidelines on a daily basis.

65%

Documentation

§ Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.

20%

Instrument Maintenance

§ Calibrates and maintains laboratory equipment according to SOPs.

5%

Technical Writing

§ Responsible for assisting with writing new SOPs or revising existing documentation.

§ Under supervision, writes Deviation Investigations (DI's), Laboratory Assessments (LA's), and Investigation Reports (IR's).

5%

GMP Compliance

§ Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.

§ Adheres to Company safety procedures and guidelines on a daily basis.

5%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

§ B.S. in a Biological Science or related field with a minimum of 0-3 years' experience in pharmaceutical or biotechnology industry required.

§ Microbiology testing experience in a pharmaceutical or biotechnology industry required.

§ General experience in a development, quality, or manufacturing environment preferred.

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