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Temp Senior QC Micro Specialist
3 months ago
Within this role you will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure departmental compliance to regulatory guidelines are maintained. Drives continuous improvements for microbiological methods.
This is a 12-month temporary contract
As a Senior QC Micro Specialist, a typical day might include the following:
Identifying, introducing, onboarding, and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures. Becoming the SMEs of these technologies, assays, and procedures Leading Test Method validations, studies, and assisting in troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity over time Applying a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations Assisting in the building of processes where gaps have been identified Leading tasks associated with aseptic process simulations Collaborating with team members on activities associated with Change Control. This includes initiating, impacting, and implementing the change; also initiating and closing workflows and CAPAs Participating in the writing of technical documents and studies to troubleshoot and support investigations Applying their expertise in the creating and updating of SOPs Leading data gathering and analysis in support of investigations and business decision-making Leading the evaluation of data entry, analysis, and reporting of microbiological data and supporting the implementation of changes to identify streamlining opportunities Suggesting alternative solutions/workarounds while obtaining buy-in from the organization Participating in internal audit discussions and seeking alignment with the team to address microbial requests Collaborating in technical discussions and problem-solving with outside entities (i.e., contract manufacturers and contract test labs) to drive resolutions Assisting in effectively communicating technical solutions to others in the organization Seeking support to make good judgments and quick decisions regarding microbiological methods Assisting in the integration of technical updates into team procedures while maintaining compliance with regulatory agencies Staying current with industry trends in QC technology Implementing the creation and review of LIMS configurations to meet the needs of QC-Microbiology, this may include implementing new specifications, designing LIMS/ELN templates for new/revised test methods, designing queries, and reporting Assisting in the collection and maintenance of reference libraries for microbiological methods Assisting others across all aspects of the team, may manage others through influence rather than direct authorityThis role might be for you if you:
You are a facilitator with organizational agility You can assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy You have Advance Knowledge in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants You have excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company You can resolve and negotiates conflicts or problems with tact, diplomacy and composure You have the ability to handle multiple priorities with exceptional organizational and time management skills You are proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance)To be considered for this opportunity you should have a BS/BA microbiology with at least 5 years of relevant experience or equivalent combination of education and experience
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