Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Microbiology Supervisor, Laboratory 2Nd Shift

Expired Job

Amerisourcebergen Corporation - Corporate Dayton , NJ 08810

Posted 3 months ago

This position will report to the Quality Organization of PharMEDium. Supervisors at this facility will supervise staff, maintain sample schedules, and perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The supervisor must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures.

  • Schedule samples for analysis

  • Support specialized projects

  • Organize the receiving, storing and logging in of samples from the clean room or inventory

  • Actively Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits. Must have the ability and experience to draft submission ready responses to audit observations.

  • Review and approve data generated by biologists

  • Maintenance of Laboratory Notebooks

  • Review and initiate the revision of standard operating procedures

  • Active knowledge of current regulatory process and updates in the area of responsibility

  • Coordinate Instrument maintenance with Laboratory Metrology

  • Coordinate Method Transfers and Method Development

  • Write and execute protocols and reports

  • Understand OOS/Investigative reports

  • Develop Quality Reports

  • Mentor and Supervise Biologists and Technicians

  • Actively participle in New Initiative involving Lab topics

  • B.S. or Masters in Biology or related field with a minimum of 8 - 10 years of pharmaceutical laboratory experience or PhD with a minimum of 5 years of pharmaceutical laboratory experience and 0-2 years of supervisory experience of multiple staff members.

  • Must have environmental monitoring experience

  • Experience in FDA regulated industry.

  • Actively participated in audits (internal and regulatory) with independent close out of observations

  • Effective organization and planning skills

  • Excellent technical and verbal skills

  • Must have the ability to multi-task

  • Have problem solving skill set

  • Computer knowledge of data collection systems and or spreadsheet software, Microsoft Word, Excel, and PowerPoint

  • Understanding and experience utilizing the USP Compendia methods

  • Knowledge of Environmental Monitoring Programs

  • Advanced Knowledge and training of microbiology testing, GMP documentation of experiments, and Endotoxin Analysis.

  • Ability to travel up to 10%

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Microbiology Laboratory Supervisor

Amerisourcebergen Corporation - Corporate

Posted 1 week ago

VIEW JOBS 11/7/2018 12:00:00 AM 2019-02-05T00:00 This position will report to the Quality Organization of PharMEDium. Supervisors at this facility will supervise staff, maintain sample schedules, and perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The supervisor must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures. * Schedule samples for analysis * Support specialized projects * Organize the receiving, storing and logging in of samples from the clean room or inventory * Actively Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits. Must have the ability and experience to draft submission ready responses to audit observations. * Review and approve data generated by biologists * Maintenance of Laboratory Notebooks * Review and initiate the revision of standard operating procedures * Active knowledge of current regulatory process and updates in the area of responsibility * Coordinate Instrument maintenance with Laboratory Metrology * Coordinate Method Transfers and Method Development * Write and execute protocols and reports * Understand OOS/Investigative reports * Develop Quality Reports * Mentor and Supervise Biologists and Technicians * Actively participle in New Initiative involving Lab topics * B.S. or Masters in Biology or related field with a minimum of 8 - 10 years of pharmaceutical laboratory experience or PhD with a minimum of 5 years of pharmaceutical laboratory experience and 0-2 years of supervisory experience of multiple staff members. * Must have environmental monitoring experience * Experience in FDA regulated industry. * Actively participated in audits (internal and regulatory) with independent close out of observations * Effective organization and planning skills * Excellent technical and verbal skills * Must have the ability to multi-task * Have problem solving skill set * Computer knowledge of data collection systems and or spreadsheet software, Microsoft Word, Excel, and PowerPoint * Understanding and experience utilizing the USP Compendia methods * Knowledge of Environmental Monitoring Programs * Advanced Knowledge and training of microbiology testing, GMP documentation of experiments, and Endotoxin Analysis. * Ability to travel up to 10% Amerisourcebergen Corporation - Corporate Dayton NJ

Microbiology Supervisor, Laboratory 2Nd Shift

Expired Job

Amerisourcebergen Corporation - Corporate