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 QA Associate I - Audits is responsible for supporting the Compliance team and Quality Management with all documentation and tracking of supplier qualification records, complaints, and supplier materials as well as client audit support. Provides administrative support to others quality staff and other departments.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Maintain computerized (Microsoft Office Software) and master document files for supplier, contractor & client audits.

• Assists with processing and completion of supplier self-audit surveys.

• Assists with coordinating supplier CDA/NDA documents.

• Ensures that BSE/TSE certificates are obtained for materials.

• Assists with receiving, documenting, and processing supplier complaints.

• Initiate processing of Supplier Initiated Changes for changes from suppliers.

• Tracking of client audit report receipt and responses and updating audit commitment tracker.

• Provides support to the Compliance Team as needed to assist in adhering to compliance requirements for established quality system programs such as but not limited to Supplier Qualification Programs and Client Audit programs.

• Perform other duties as assigned.

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Proven ability to multi-task, as directed, in an extremely fast-paced, dynamic environment with changing priorities.

• Strong computer skills in MS Office including Word, Excel, Outlook, Access, PowerPoint

• Excellent verbal and written communication skills required.

• Self-motivated individual with a desire to expand QMS knowledge.

• Detail oriented and a result driven team player.

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.

• Associates degree with a minimum of 5 years’ experience in a cGMP environment: 0-2-year previous experience with bachelor’s degree

• Experience working with internal cross-functional teams to coordinate and facilitate documentation and information retrieval.

• Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment preferred.

• Working knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820), Guidance’s, and ICH is preferred; EMEA and other agency regulations is a plus.

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled