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Compliance Specialist I - Biotech (Remote)

  • Location: San Diego
  • $ Salary: US$27.00 - US$33.00 per hour per hour
  • Job Type:Contract

Posted 26 days ago

  • Sector: Life Sciences
  • Contact: Calum Nelson
  • Duration: 3 months
  • Start Date: 22/01/2024
  • Expiry Date: 25 February 2024
  • Job Ref: JN -012024-483471

Location: San Diego, CA/Remote
Duration: 3-Month Contract
Schedule: Standard Office Hours
Pay Rate Range: $27.00- $33.00/ph

The 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 practitioner
  • 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.

Qualifications 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