QC Senior Analyst - Microbiology

Quality & Compliance Horsham, Pennsylvania


Description

Job Summary - a concise overview of the job

The QC Senior Analyst – Microbiology provides microbiological expertise for the Quality Control (QC) Microbiology department, specifically in the areas of microbiological testing, environmental monitoring, test method and standard operating procedure (SOP) revisions. This role also responsible for writing change control, deviation, CAPA, and investigational reports. Key areas of focus are release and stability coordination, microbiological testing, release of in-process, intermediates, finished products and testing for validation purposes.  The QC Senior Analyst – Microbiology applies critical thought and utilizes in-depth knowledge to solve problems of complex scope. 

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.

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.

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

20%

Technical Support

§  Acts as technical liaison between QC and outside departments or contractors / subsidiaries.

§  Identifies and supports assay troubleshooting efforts.

15%

Technical Writing & Investigations

§  Authors new SOPs and/or revises existing documentation.

§  With minimal oversight, prepares validation protocols, executes experiments, and prepares validation reports.

§  Writes Change Controls, Deviation Investigations (DI’s), Laboratory Assessments (LA’s), CAPA’s and Investigation Reports (IR’s).

§  Assists and/or trains less senior QC Analysts - Microbiology with technical writing.

15%

Documentation

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

10%

Data Review

§  Reviews microbiology data for accuracy and compliance with department procedures.  Addresses any results that do not comply with acceptance criteria or specifications.

10%

Technical Development

§  Provides technical leadership to the laboratories for method optimization, transfer, implementation, and validation.

10%

Technical Transfer

§  Coordinates bioanalytical technology transfer from outside departments and to outside contractors. 

§  Provides training as required for transfers.

5%

Instrument Maintenance

§  Calibrates and maintains laboratory equipment according to SOPs.

§  Identifies and troubleshoots equipment problems.

5%

GMP Compliance

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

§  Prepares documentation for presentation to Regulatory Agencies.

5%

Other Tasks

§  Applies critical thought to solving problems of complex scope.

§  Works on complex problems requiring an in-depth knowledge of scientific methods and techniques.

§  Acts independently to determine methods and procedures on new assignments.

§  Performs other duties as assigned by QC management.

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 7+ years’ experience in pharmaceutical or biotechnology industry required OR

§  M.S. in a Biological Science or related field with a minimum of 5+ years’ experience in pharmaceutical or biotechnology industry.

§  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.

§  Expert knowledge of microbiology testing (i.e., Purified Water, WFI, Nitrogen, Compressed Air, Environmental Monitoring, bioburden, endotoxin, TOC)

§  Strong knowledge and technical expertise 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.

§  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.

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

§  Excellent interpersonal skills and flexibility.

§  Understanding of basic statistical analysis and familiarity with the use of databases is desirable.

§  Advanced writing skills.

§  Proficient in running a great number of methods.

§  Apply acquired biopharmaceutical skills to project and assignments.

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.