Senior Analyst 1, QC Microbiology

Position Overview The Sr. Analyst 1, QC Raw Materials is accountable for GMP compliant laboratory operations according to USP/EP/JP regulations. The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory. Following Tech-Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods. What You'll Do Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.) Support QC Raw Materials team on internal tech transfer meetings related to new products Under supervision and support, author and review procedures, protocols, reports and specifications related to the raw material area Perform testing and disposition of incoming raw materials and components according to specifications and procedures Assess and execute actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs Responsible for initiation and execution of Trackwise deviations, CAPAs, lab exceptions and invalid assays Author and implement corrective and preventative actions from approved deviations, CAPAs, lab exceptions and invalid assays in Trackwise Perform routine investigations in support of out of specification testing results Support maintenance of effective laboratory systems to ensure integrity of all laboratory results Enforce established policies and procedures and escalates to management areas where enhancements will improve daily work Assist Manager, QC in the implementation of new technologies Adhere to pre-defined turnaround times of raw material testing Review new and updated specifications Assess lab exceptions and perform routine investigations Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated Perform other duties as assigned Minimum Requirements B.A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline 1-3 years relevant experience Previous experience in a GMP environment Computer proficiency required Preferred Requirements Masters degree in Biology, Chemistry, Biochemistry, Microbiology or other relevant scientific discipline with 0+ years experience Familiar with Raw Material methodology as it pertains to cGMP Experience in assay troubleshooting and problem solving Physical and Work Environment Requirements Ability to discern audible cues Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color Ability to stand for prolonged periods of time up to 240 minutes Ability to sit for prolonged periods of time up to 240 minutes Ability to conduct activities using repetitive motions that include writes, hands and/or fingers Ability to conduct work that includes moving objects up to 10 pounds Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions Will work in warm/cold environments (5°C) Will work in small and/or enclosed spaces EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io). #J-18808-Ljbffr Merck & Co.