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The opportunity
This position performs advanced microbiological testing on drug products and maintains appropriate records; provides lead supervision and training to more junior staff and performs highly technical and specialized duties.  The Manager Quality Control – Microbiology will have a key role in the implementation of in-house microbiological testing lab.  Sends samples to contract microbiological laboratories when needed and interacts with them to solve microbiological testing issues and tracks and archives test results and reports. Writes technical reports for regulatory submission. 
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. 

Will oversee implementation of in-house microbiological testing including validation of methods, setting up the laboratory, scoping out equipment, etc.
Will oversee implementation of appropriate clean-room environmental monitoring programs.
Will oversee implementation and remediation of microbial risk assessments for the manufacturing facility.
Tests finished product test samples or sends them out to contract laboratory for analysis. Oversees the work of junior microbiologists and reviews their test data and the quality of their data review.
Prepares media used in the microbiological testing of drug products and components.
Prepares samples for shipment to outside contract laboratory for microbiological testing.
Performs advanced microbiological testing on drug products.
Validates microbiology test methods.
Reviews data generated by other Microbiologists and outside contract laboratories.
Trains Junior Microbiologist on microbiology test methods.
Drafts Standard Operating Procedures (SOP) for the microbiology laboratory.
Prepares written reports of any investigations conducted.
Ensures compliance with current Good Manufacturing Procedures (cGMP) requirements at all times.
Responsible for prioritizing and coordinating testing of raw material, in-process, bulk product, packaged finished product, stability samples, micro samples, and/or water samples for analysts, as needed to support manufacturing. Assist in the checking/auditing of raw data and various logs generated by analysts.  
Responsible for liaising between QC functional groups (Finished Product, Raw Materials, Sampling, etc) and internal and external partners to set priorities and schedules to meet timelines.
Responsible for generating a rolling daily/weekly Master Planning Schedule for Quality Control Lab based off the priority of Operations.
Responsible for compiling QC Metrics (internal and corporate) and communicating within and above site as required.
Responsible for conducting or coordinating the creation of Incident, Deviation and Out of Specification Investigation and Out of Trend Investigation reports.
Responsible for assisting in maintenance of equipment and computerized systems as needed.  This includes overseeing maintenance, qualification and GMP status of laboratory instruments needed for sample analysis or other analytical work.  
Responsible for performing complex revisions to Standard Operating Procedures, Test Methods, and Specifications. 
Responsible for coordinating and designing activities associated with the stability program including sample management activities and data analyses and performing statistical analyses.  
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOP’s) and Batch Record instructions. 
Responsible for performing additional related duties as assigned.