BEPC is looking for a Quality Compliance Lead in Oceanside, CA to join our fast-growing team of consultants!
W2 Contract: 7 months with opportunities for extensions based on business needs and performance.
Pay Range: $68.01-89.72/hr. plus we offer Medical, Dental, Vision and Life Insurance benefits!
Schedule: 100% Onsite in Oceanside
Job Summary:
The local Quality compliance lead will ensure appropriate local Aspire activities and deliverables meet Compliance expectations. Ultimately, the local lead will be accountable for ensuring the site is “inspection ready”. The local Compliance Lead will work closely with core counterparts to understand the core deliverables and to ensure local compliance efforts are complementary to those produced on behalf of the wider program. Locally, the Lead will ensure local Change requests, Protocols, CSV & quality deliverables, Plans and Reports are all completed in alignment with project plans/timelines and to ensure that any compliance risks are mitigated.
Key Responsibilities/On-going Tasks:
- Follow-up on CIAs that require Compliance Evaluation Required and determine the impact on site.
- Oversight of PE as Additional Quality Approver.
- Pending Closure of Quality Risk Management Impact Assessment.
- Pending Closure of Quality Controlled Document Impact Assessment.
- Pending Initiation and Closure of Training Assessment.
- Pending Linkage to the Data Integrity Impact Assessment.
- Pending Closure of Validation Impact Assessment.
- Review and provide input to EIN/GPN/FL Change Document Impact Assessment and Next Steps for Local Procedures.
- Begin drafting OCN's Deployment End to End Test Plan.
Experience:
- Minimum education is a Bachelor’s degree in relevant field.
- Experience with Change records, change controller, planned events and approvals, Inspection readiness.
- Ideal candidate should have approximately 5 years of relevant experience in Quality Management in a pharmaceutical environment.
USOPS