Quality Specialist

Job ***** Quality Specialist - I***** Elkton, VA 22827100% onsite***** 12+ Months contractRotating shift role with the following ***** 6:30am - 3:30pm and 1:30pm - 10:30pmJob **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 A/B/C) areas which also includes getting certified for Grade A/B gowning.May perform quarantine functions and accountability reviews. Supports special projects as assigned.The role follows cGMP and routinely makes decisions using cGMP/process 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 tracks/reports metrics as needed.May provide training/ presentations as needed.May help with regulatory inspectionsQuals--Education Minimum *Bachelors Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.Required Experience and *Previous Experience in the pharmaceutical industry.Preferred Experience and *Previous experience supporting aseptic operations or sterile products, experience in Quality Assurance/Engineering role or technical role.Previous experience in food or pharmaceutical environment in regulatory/inspection role.Previous experience in project management, process data analysis.Lean Six Sigma CertificationPrevious Experience with SAP, MEDS, etc.*Beta Lactam screening is required for this role.Shift *This will be a rotating shift role with the following **** 6:30***** and 1:30***** The successful candidate will support aseptic operations on rotating shift.

Created: 2025-02-20