Compliance Specialist

Compliance Specialist

5 Months (Extendable)

San Diego, CA

Max PR: $25-33/hr

Summary

• 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

• 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.

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