Overview
Quality Specialist Jobs in Elkton, Virginia, USA at TALENT Software Services
Position: Quality Specialist – I
Location: Elkton
The individual carries out a variety of activities to support manufacturing operations, becoming familiar with site processes, procedures, and policies as they develop 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. Follows 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 one or more teams.
The individual tracks/reports metrics as needed. May provide training/presentations as needed. May help with regulatory inspections.
Qualifications:
Education Minimum Requirement: Bachelor’s degree in Science, Health Science, Engineering, or related discipline with 1-3 years of industry experience.
Required Experience and Skills: Previous experience in the pharmaceutical industry.
Preferred Experience and Skills: Previous experience supporting aseptic operations or sterile product, 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 Certification, previous experience with SAP, MEDS, etc. Additional:
Beta Lactam screening required for this role.
Shift Requirements: This will be a rotating shift role with the following hours: 6:30 a.m.
– 3:30 p.m. and 1:30 p.m.
– 10:30 p.m. The successful candidate will support aseptic operations on a rotating shift.
Seniority Level
Not Applicable
Employment Type
Full-time
Job Function
Other
Industries
IT Services and IT Consulting
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Title: Quality Specialist
Company: TALENT Software Services
Location: Elkton, Virginia, USA
Category: Quality Assurance – QA/QC, Healthcare
