["QC Analyst II *PC 610","QC Analyst II *PC 610"]

Role OverviewThis position is primarily responsible for the complete development, qualification and performance of environmental monitoring and microbiological QC assays to support GMP manufacturing operations in a Phase I/II multi-product biologics facility. Responsibilities include development, qualification and execution of environmental monitoring processes and microbiological assays, development and review of trend reports, SOPs, batch related EM results, and other controlled documents.Essential Duties and ResponsibilitiesDevelop and execute environmental monitoring in ISO5/7/8 clean rooms.Develop and execute microbiological assays, such as sterility.Adhere to all applicable SOPs for clean rooms, quality control and quality assurance.Develop GMP documentation such as trend reports, SOPs and documents to support equipment operation.Be responsible for proper maintenance and use of equipment in strict accordance with cGMPs, SOPs and safety policies.Lead EM investigations.Serve as a key resource establishing EM testing requirements.Trend EM data and investigate all OOL specifications; identify counts and assist in implementing CAPA.Work with QA, Manufacturing, Development and others to troubleshoot issues.Ensure adherence to EM schedule.Develop and implement training plans for QC EM Analyst I on the EM Program.Train manufacturing and QA team members on EM program requirements.Ensure quality standards are always met or exceeded.May assist in audits.Other duties as assigned.RequirementsB.S. Biology, Chemistry, Biotechnology, or related field; 2+ years of experience in environmental monitoring.Knowledge / Skills / AbilitiesKnowledge of cGMP or GLP regulations is essential.Comprehensive GMP environmental monitoring experience is required.Previous experience working in the QC department of a Biotech Company is preferred and impeccable aseptic technique.Experienced with MS Office: Word, Excel, and PowerPoint.Physical DemandsThe employee is required to walk, use hands and arms, talk, hear, stand, climb, balance, stoop, kneel, crouch, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Work EnvironmentThe work environment is a temperature-controlled facility without exposure to extreme temperatures, in a clean laboratory setting with standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. Employees are exposed to viruses and bacteria and must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. Noise level is usually moderate.Salary, Benefits & EEOHiring range: $38.75 - $45.63 per hour, based on experience, internal equity, and qualifications. The salary of the finalist(s) selected will be set based on a variety of considerations. In addition, the company offers a comprehensive benefits package, including health, vision, and dental insurance, and a 401(k) plan. Certain positions may be eligible for additional compensation such as bonuses or commissions.EEO & AccommodationsMiltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity. Miltenyi Biotec, Inc. participates in E-Verify. The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.#J-18808-Ljbffr