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Quality Specialist - I (Assistant)

Elkton, VA 22827

Posted: 03/17/2023 Employment Type: Contract Job Category: QA/Automation Job Number: 549692 Is job remote?: No Country: United States

Job 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 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 1 or more teams.
  • The individual tracks/reports metrics as needed.
  • May provide training/ presentations as needed.
  • May help with regulatory inspections.
  • Position may require shift work 2-3 times per year, for a period of 5 days. Must be flexible to accommodate this need.

  • Education Minimum Requirement: Bachelor's Degree in Science, Health Science, Engineering, or related discipline with 1-3yrs industry experience.
  • 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, Midas, or Trackwise.
Pay Range: 30-39/hr
Salary will be commensurate with experience
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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