Sr. Compliance Associate I

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.

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.

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.

• 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 Services cultural values and aligns daily actions with department goals and company culture.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• 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.

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

• 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.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• constantly required to sit, and to reach to use computers and other office equipment

• constantly stand for extended periods of time, up to four (4) hours/time.

• frequently required to lift up to 40 pounds

• constantly required to view objects at close and distant ranges with hand and eye coordination

• frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:

Employee will work with moderate noise level.  Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials.  The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy w