Quality Assurance

  • location: Social Circle, GA
  • type: Contract
  • salary: $41.46 - $48.78 per hour


Chat with me now! - https://flashrecruit.com/jobs/296600

Operations Analyst - Senior (GMP QA role)

Job Responsibilities

  • Drive maintenance compliance deliverables to ensure successful commercial operations, including:
  • Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:
  • Lead problem solving and root-cause analysis sessions
  • Interact with Manufacturing, Quality, Engineering and Tech Service units
  • Manage complex investigations using DMAIC tools
  • Ensure effective implementation of corrective and preventive actions
  • Lead investigations to resolve Out Of Tolerance instrument and equipment calibrations
  • Author and revise GMP documents, SOPs and engineering documents (e.g. PNIDs, Job Plans, Calibrations Procedures, ICLs, ICAs, Maintenance Assessments, Equipment Lifecycle, etc.)
  • Train staff in general compliance calibration and maintenance procedures
  • Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
  • Identify and implement improvement initiatives to improve calibration, equipment reliability, and/or maintenance process robustness. This may require leading and implementing change controls
  • Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
  • Stay current with biopharmaceutical industry best practices and technologies
  • Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.
  • Gather and analyze empirical data, organize, maintain and present metrics and key performance indicators.

Education & Qualifications

  • Bachelor of Science or Technical degree required
  • 0-4 years work experience
  • Professional (GMP industry) experience ideal but not required Working Environment:
  • May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry)
  • May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. Company provides PPE
  • May be required to work weekends, evenings, and off-hours, extended periods of time
  • Strong problem solving and analytical skills are required.
  • Possess knowledge of core manufacturing principles and support systems
  • Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross functional teams and management on recommended course of action, with minimal assistance.
  • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
  • Self-driven individual that requires minimal supervision
  • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
  • Working Flexible or alternate shifts may be required based on business needs.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296600

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