Sr. Compliance Associate I

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.

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; 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

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 have

At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing preferred; Personable and highly knowledgeable of the Quality Management System

Benefits

Annual performance bonus; Paid time off; Health insurance coverage (including dental and vision); Flexible spending account; 401(k) plan