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Compliance Specialist I

San Diego, CA 92122

Posted: 07/19/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 609084 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 27-33.75/hr **salary will be commensurate with experience 

Summary:


Compliance Specialist I maintains Quality Compliance by being aware of quality requirements preparing standards metrics standard operating procedure SOP management supporting audits Quality Investigations and Corrective and Preventive Actions CAPA analyzing and verifying documentation and reviewing process changes Key Responsibilities
  • Entry level Quality Management System QMS and project management practioner
  • Assists with data mining information gathering to support presentations and tracking information for projects as instructed
  • Learns organizational change management principles and practices
  • Supports Quality Investigation/CAPA implementation
  • Manages low complexity projects audit response CAPA Quality Plan with supervision. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally
  • Learns to develop program and project plans including detailed timelines with durations dependencies critical path and milestones
  • Develops awareness of facilitation and negotiation as well as the ability to drive to decisions
  • Relies on team to identify risk
  • Gains experience with problem-solving / root cause tools
  • Individual contributor
  • Contributes to an inclusive respectful and safe work environment

Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Minimum Requirements:
  • Bachelor's Degree Chemistry Biology Microbiology or another scientific field or equivalent experience
  • less than 1 year Experience in life sciences industry or related experience Direct experience working in in-vitro diagnostic or bio-pharmaceutical manufacturing environment preferred

Preferred Qualifications:
  • Quality Certification preferred e.g. CQE CQA SQE 6-sigma or similar certifications within 1-1/2 Yrs
  • Proficiency with MS Office applications ex: Word Excel PowerPoint Visio and other tools for data analysis ex: Tableau Lucid chart Asana preferred
  • Project Management skills a plus
  • PMP certification or similar training a bonus within 1-1/2 Yrs
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