Sr. Compliance Associate I

PCI Pharma Services • San Diego, CA

5d • $30 - $33

About The Position

The Sr. Compliance Associate I will utilize their skills to hosts customer and regulatory audits, assist in the execution of internal audits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable and highly knowledgeable of the Quality Management System.

Requirements

• Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required.
• Minimum of 6 years of relevant QA experience in a regulated industry.
• 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.

Nice To Haves

• At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing preferred.

Responsibilities

• Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
• Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
• Supports the execution of internal audit program
• Supports risk management program
• Supports the continuous improvement of the Quality Management System
• Reviews and approves quality management system standard operating procedures (SOPs)
• Reviews and approves deviation reports and CAPAs related to quality systems
• Generates quality system metrics for management review meetings
• Trains team members on conducting internal and external audits
• 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 Serivices cultural values and aligns daily actions with department goals and company culture.

Benefits

• paid time off
• health insurance coverage (including dental and vision)
• a flexible spending account
• a 401(k) plan
• annual performance bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level