QC Analyst l - Microbiology

Quality & Compliance Horsham, Pennsylvania


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.

 


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.

§  Functional and technical knowledge of 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.

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.

§  Strong verbal and communication skills required.

§  Proficient in common software applications.

§  Ability to handle multiple priorities in a fast paced environment.

§  Demonstrates excellent interpersonal skills and flexibility.

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.

§  Lifting up to 40 lbs.

§  Able to climb ladder for sampling.

§  Able to stand for extended periods of time.

§  Ability to wear a sterile gown and don shoe covers on a periodic basis.

 

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.