Quality Specialist - I - Katalyst Healthcares & Life Sciences : Job Details

Quality Specialist - I

Katalyst Healthcares & Life Sciences

Job Location : Elkton,VA, USA

Posted on : 2024-12-08T08:52:22Z

Job Description :
Responsibilities:
  • 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.
Requirements:
  • 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.
  • 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.
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