Sr. Compliance Associate I
$29,650–$33,360 year
On-siteSan Diego, California, United States
Job Summary
Host customer and regulatory audits, assist in internal audit execution, and support the vendor management program. Lead customer audits while collaborating with Subject Matter Experts to address findings and track the program for continuous improvement. Support the execution of internal and external audit programs, establish Quality Agreements, and review SOPs, deviation reports, and CAPAs. Generate quality system metrics for management review and train team members on auditing procedures. Requires full-time attendance, a Bachelor's degree in Life Sciences, and minimum six years of QA experience in a regulated industry.
Required Qualifications
- Bachelor's Degree in a Life Sciences discipline
- Minimum of 6 years of relevant QA experience in a regulated industry
- At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing
- Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing
- Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
- Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing
- Detail-oriented with strong organizational skills
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule]
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices
- Embodies PCI Pharma Serivics cultural values and aligns daily actions with department goals and company culture
Desired Qualifications
- At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing preferred
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