Quality Assurance Engineer

Elkton, Virginia

 Integrated Resources
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Job Title: Quality Assurance Engineer
Location: Elkton, VA
Duration: 12 Months+

Shift Requirements:
  • This will be a rotating shift role with the following hours: 6:30 am - 3:30 pm and 1:30 pm - 10:30 pm. The successful candidate will support aseptic operations on rotating shift.
Job Description:
  • The individual carries out a variety of activities to support manufacturing operations by 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 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 1 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 1-3yrs 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.
Date Posted: 05 May 2025
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