Reagent Quality Technician

Company: Aerotek
Location: Ann Arbor
Posted on: February 18, 2021

Job Description:

Description:Position summary:Primarily wet bench workwriting and following SOPS The QC Technician, Reagents is responsible for QC testing of intermediate and final reagent production using bench top techniques as well as using the Molecular System to QC material.In this position the QC Technician, Reagents will assist in maintaining QC equipment, train others, may be asked to contribute to projects, and trained to work in several areas as needed. This role requires a self-starter, with the ability to work independently, understanding of departmental goals, and work as a team to achieve those goals within set timelines.The position is responsible for working closely with the Investigations Team to carry out non conformance investigations, as well as investigations to support CAPAs.Technician must be detail oriented and adept at learning new software interfaces. Role and Responsibilities:Perform QC testing of intermediate and final product per standardized procedures.Be proficient at micropipetting and common laboratory techniques, calculations, and statistics.Perform nucleic acid extractions (RNA and DNA) using novel extraction procedures and perform Real time PCR. Analyze data using established worksheets and develop new templates for data analysis.Work in a BSL2 level laboratory using appropriate precautions, including working with human blood products and other clinical samples.Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives.Draft and edit new SOPs for QC procedures. Assist in maintaining calibrated pipettes and instrumentation..Be committed to following and supporting safety practices.Prepare for testing by reviewing work orders, production schedule, collecting materials and supplies. Set-up equipment necessary for different functional tests.Document final testing by completing applicable forms, reports, logs, and records equipment and batches using cGLP practices.Maintain and implement trending of QC data and communicate results of trending to management team.Keep work areas clean and organized, keeping with 5S principles.Effectively communicate with Reagent Production, Assay Development and other management teams.Contribute to Continuous Improvement efforts; Identify and help implement process, procedure, and safety improvements.Complete and maintain training records within expected timelines.Train/mentor less experienced QC Test Technicians.Complete other tasks as needed.Qualifications/Experience:Must have functional understanding of cGMP's and cGLP, and the impact of deviating from controlled processes and/or procedures.College Degree in biochemistry, microbiology or molecular biology plus 3-year relevant work experience, or Associates degree and 5-years relevant work experience.Must have working knowledge and understanding of ISO13485, 21 CFR 820Excellent written, verbal and analytical skills and the ability to thrive in a challenging, fast-paced multidisciplinary setting Proficiency with Microsoft Word, Excel and PowerPoint for data analysis and report generation a must.Skills:PCR, pipetting, batch records, analyzing, Data Analysis, SOPTop Skills Details:MUST HAVE: Bachelors in Molecular, micro, or any life science 2-3 years experience in real time PCR 2-3 years experience in small volume pippetting Advance Excel experience NICE TO HAVE: writing SOPsAdditional Skills & Qualifications:MUST HAVE: Bachelors in Molecular, micro, or any life science 2-3 years experience in real time PCR 2-3 years experience in small volume pippetting Advance Excel experience NICE TO HAVE: writing SOPs About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Ann Arbor , Reagent Quality Technician, Professions , Ann Arbor, Michigan