Quality Specialist
Net2Source Inc. - new york city, NY
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Job Title: Quality Specialist - ILocation: Elkton, VA 22827100% onsiteDuration: 12+ Months contractRotating shift role with the following hours: 6:30am - 3:30pm and 1:30pm - 10:30pmJob Description:The individual carries out a variety of activities to support manufacturing operations, becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.The role will support the review and approval of qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality related documentation.The successful candidate will support aseptic operations on shift, including auditing of classified (Grades ABC) areas which also includes getting certified for Grade AB gowning.May perform quarantine functions and accountability reviews. Supports special projects as assigned.The role follows cGMP and routinely makes decisions using cGMPprocess knowledge.May work with customers to resolve problems and to satisfy quality and production needs.Follow site safety requirements.Authors, reviews, and approves data documents such as methods, procedures, and or protocols.Performs all work and completes assignments in a timely manner and is an active member of 1 or more teams.The individual tracksreports metrics as needed.May provide training presentations as needed.May help with regulatory inspectionsQuals--Education Minimum Requirement:Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.Required Experience and Skills:Previous Experience in the pharmaceutical industry.Preferred Experience and Skills:Previous experience supporting aseptic operations or sterile products, experience in Quality AssuranceEngineering role or technical role.Previous experience in food or pharmaceutical environment in regulatoryinspection role.Previous experience in project management, process data analysis.Lean Six Sigma CertificationPrevious Experience with SAP, MEDS, etc.Additional:Beta Lactam screening is required for this role.Shift Requirements: This will be a rotating shift role with the following hours: 6:30a-3:30p and 1:30p-10:30p. The successful candidate will support aseptic operations on rotating shift.
Created: 2025-02-21