Compliance Associate II

PCI Pharma Services • San Diego, CA

1d • $37 - $41

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Perform moderately complex activities pertaining to assuring compliance with applicable regulatory requirements. Conduct internal audits; assist with customer audits, and track audit corrective actions. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

Requirements

• Bachelor’s degree in Life Sciences discipline or equivalent preferred.
• Minimum of two to four (2-4) years of experience in a GMP environment.
• Basic understanding of regulatory requirements related to aseptic drug product manufacturing and testing
• Good understanding of internal requirements related to quality management systems, risk management, and supplier qualification
• Developing communication and team collaboration skills
• Detail-oriented with strong organizational skills
• Proficient with Microsoft Office applications

Responsibilities

• Assists with internal audit program by conducting audits, writing audit reports, evaluating responses to audit observations, and verifying closure of corrective actions.
• Assists with vendor quality program by conducting paper audits and tracking vendor quality issues and changes.
• Assists with customer audit program by retrieving and preparing documentation, communicating and coordinating with internal SMEs, and tracking completion of corrective actions.
• Assists with regulatory inspection process by retrieving requested documentation and communicating with SMEs.
• 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’s cultural values and aligns daily actions with department goals and company culture.

Benefits

• PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

What This Job Offers

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