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Deviation Specialist

Company: Aerotek
Location: Lenoir
Posted on: January 15, 2022

Job Description:

Quality Control Deviations Specialist Lenoir, NCPosition:Quality Control Deviations SpecialistPlacement:12-Month Contract-To-HireLocation:Lenoir, NCSchedule:Monday - FridayShift:1st shift, 8:00AM 5:00PMPay: $31 38/hr. Pay based upon experience.Qualifications:Bachelor of Arts or Science in Chemistry, Biochemistry, or Biology required.5 7 years of experience in Quality Control Chemistry Laboratory in the pharmaceutical industry.Must have previous experience performing Laboratory investigations including Out of Specification (OOS) and Out of Trend (OOT) results.Must have a thorough understanding of the pharmaceutical manufacturing process and equipment, current Good Manufacturing Practices (cGMPs).Must have a thorough understanding of Good Laboratory Practice (GLP).Previous experience analyzing samples using HPLC, GC, ICP-MS, HPIC, AA and GCMS.Must be familiar with USP General Chapters, Monographs, and General Notices.Must have good analysis, troubleshooting, and investigation skills.Familiar with Empower 3.Technical writing skills.Familiarity with an Electronic Quality System such as TrackWise is preferred.Responsibilities:The QC Deviation Specialist will lead investigations of deviations that occur within the QC Laboratory during the testing of finished drug products and raw materials, i.e., laboratory errors, out of specification and trend results, and unusual occurrences for the QC Chemistry department.Assist departments facility-wide with deviation investigations.Determine the level of investigation a situation warrants (occurrence versus deviation).Assist with and review root cause investigations.Ability to navigate, review, and approve items in TrackWise Digital.Drive investigations to completion by their due dates.Report metrics on a weekly/monthly/quarterly basis.Create and provide back-up support for: SOPs, change controls, CAPAs, complaints, and/or audits.Partner with quality assurance, operations, engineering, maintenance, calibration, safety, supplier quality management, technical services, subject matter experts, and quality approvers to ensure appropriate and timely determination of scope, potential product impact, root cause, and corrective and/or preventative actions.Interact will all levels of staff and provide status updates as well as present the strategy for closure of deviations.Author and manage several investigations simultaneously to meet key timing commitments, with well-investigated and well-documented deviation reports.Determine scope, potential product impact, root cause and corrective actions for deviations.Determine appropriate preventative actions to prevent recurrence of the deviation.Author Laboratory Occurrences.Create CAPAs, Change Controls, and Standard Operating Procedures.Train personnel on authoring investigations. About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.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, Gastonia , Deviation Specialist, Other , Lenoir, North Carolina

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