Senior Microbiologist at Totowa

Job Description

A fast growing Biotech company is looking for a Senior Microbiologist to work for their Quality Operations group and reports to Associate Director of Site GMP Compliance.

 

• Provide microbiological services support for all manufacturing activities. 
• Participates in activities such as environmental monitoring, media fills, microbiological and chemical sampling of utilities and services. 
• Perform quarterly and annual data analysis, archiving and trending of Environmental Monitoring and utilities data. 

RESPONSIBILITIES:

• Performs environmental monitoring (viable/nonviable), sampling and testing according to established written procedures.
• Develops and write/revises written procedures as necessary with minimal supervisory input.
• Leads laboratory investigations for out of specification (OOS) microbiological testing results, other microbiological laboratory non-conformances.
• Leads investigations for root cause into environmental results that exceed set limits.
• Maintains all records in a complete and organized manner
• Develops new techniques and procedures to meet compendia regulations as well as to permit the maximization of in-house testing.
• At the request of Quality Assurance Department, assist in vendor audits
• Keep abreast of new technologies in microbiology, evaluate and investigate their applications for the laboratories.
• Updates, audits and maintains QC test records.
• Generates QC testing reports, change controls, work orders
• Supports activities including the maintenance and calibration of QC instrumentation.
• Supports new test method development as well as transfer and method validation activities.
• Keeps current with FDA and cGMP standards and industry trends.
• Must be able to work flexible hours as needed to support manufacturing schedule
• Performs Microbial Limits testing of Actives and Excipients
• Performs Bioburden testing on In process bulk solutions
• Performs Nitrogen and Compressed gas monitoring
• Performs Bacterial Endotoxin testing (gel clot/kinetic)
• Ensures all supplies related to microbiological monitoring are maintained
• Contributes to training on subjects related to aseptic technique and processing
• Contributes to procedures and methods in relation to microbiological monitoring
• Maintains microbiological results to facilitate reporting, tracking, trending and associated metrics.

 

CUSTOMERS OR CLIENTS:

• Manufacturing Operations
• Quality Assurance
• Contract Laboratories

Please respond directly to Global Employment Solutions, Inc. at [Click Here to Email Your Resum] with your resume attached – If you choose to respond on line through CareerBuilder.com, please do attach your resume in WORD document.

Job Requirements

REQUIREMENTS

• Requires a Bachelors/Masters degree in a Microbiology, Biology or equivalent

• 5-7 years of experience as a Microbiologist in the pharmaceutical industry with emphasis in supporting aseptic production and microbiological laboratory methods.

• In-depth knowledge of microbiology operations within pharmaceutical manufacturing operations
• In-depth knowledge of microbiological techniques and methods supporting the manufacture, storage and distribution of sterile drug products
• In-depth knowledge of aseptic processing
• Knowledge of cGMPs, ICH and other related guidelines and directives for sterile pharmaceuticals
• Ability to multi-task and manage priorities
• Ability to interface at all technical levels
• Provide training in basic microbiology and aseptic technique
• Requires strict attention to accuracy and detail.
• Ability to efficiently utilize a computer and Microsoft Office software.

Keywords: Senior Microbiologist, Microbiologist, Microbiology, microbiology operations, microbiological techniques, OOS, microbiological testing results, microbiological laboratory non-conformances, GMP, Bioburden testing, Nitrogen and Compressed gas monitoring, Bacterial Endotoxin testing

 
 
To apply - please call Rose Chu at #610-822-1256 to discuss details or send your updated resume to [Click Here to Email Your Resum] directly for interview.

 

We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client’s interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Sr. Microbiology) in the subject line of your correspondence to ensure review. Please forward your credentials in Word format, in confidence, to: [Click Here to Email Your Resum] Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews

Country: USA, State: New Jersey, City: Totowa, Company: Global Employment Solutions Inc..