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Quality Specialist - I (Assistant)

Astrix Technology Group
Elkton, VA Full Time
POSTED ON 4/25/2024

Job Description:

  • Assist in various activities to facilitate manufacturing operations, gaining familiarity with site processes, procedures, and policies, alignment with cGMPs and Health Authority regulations.
  • Review and approve qualification activities, change controls, batch records, investigations, procedures, and other quality-related documentation, ensuring compliance with regulatory standards.
  • Provide support for aseptic operations on shift, including auditing of classified areas.
  • Adhere to cGMP standards and safety requirements, based on cGMP/process knowledge, and contributing to the maintenance of a safe work environment.

Job Requirements:

  • Bachelor's Degree in Science, Health Science, Engineering, or related discipline with
  • 1-3 years of industry experience, in pharmaceutical industry.
  • Preferred Skills: Experience in Quality Assurance/Engineering or Technical roles, familiarity with regulatory/inspection processes in food or pharmaceutical environments, proficiency in project management and process data analysis.
  • Lean Six Sigma Certification preferred. Familiarity with SAP, MEDS, or similar systems is a plus.
Additional Requirements: Beta Lactam screening is mandatory for this role.
Shift: 8 am to 5 pm
Pay: Up to 39.92 per hr

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