Quality Assurance Specialist 3rd Party Products

As part of the Batch File Review Team at PCI, your role will involve compiling and reviewing batch documents across various process types such as OSD, Sterile, Biologics, Cell Therapy, and Gene Therapy. You will work closely with internal and external stakeholders, preparing documentation for Quality Person (QP) review, coordinating corrections, and ensuring compliance with regulatory requirements. This position offers a diverse range of responsibilities and serves as an ideal foundation for those considering a future career as a QP. Key Responsibilities: - Compile and review batch documents, ensuring accuracy and completeness prior to QP review. - Collaborate with site personnel to address any required corrections and prepare Certificates of Compliance (COC) for QP approval. - Conduct batch file reviews for products manufactured/packed at PCI or third-party facilities. - Raise and report deviations, corrective actions, and non-conformance issues promptly, ensuring timely resolution. - Request and review Certificates of Analysis/Conformance for API/Drug Substance, Bulk Product, and Packaging records. - Coordinate product supply chain activities, including imports and exports to the European Union. - Participate in customer meetings to discuss and summarize necessary quality documentation. - Develop and update Standard Operating Procedures (SOPs) and work instructions as needed. - Maintain batch documents and retain samples in the archive room, updating the Product Quality Review (PQR) database post-QP release. - Ensure adherence to safe work practices and report any incidents to the Environmental Health and Safety (EHS) Department. - Perform additional tasks as required to support the company's overall objectives. Essential Requirements: - Degree and/or relevant experience in a related field. - Previous experience with Good Manufacturing Practices (GMP) and Sterile manufacturing. - Strong communication skills and ability to problem-solve effectively. - Minimum of 2 years of experience in Quality Assurance roles. - Demonstrated track record of achieving results through leadership and management. - Proven ability to set and achieve clear goals within defined timelines. Join us at PCI and play a vital role in bridging life-changing therapies to patients. Let's shape the future together. Equal Employment Opportunity (EEO) Statement: PCI is committed to fostering an inclusive workplace environment that upholds the values of equity and inclusion. We strive to create a culture of understanding, respect, and equal opportunity for all individuals at every level of the organization. By continuously assessing our practices, policies, and programs, we aim to build a community where everyone feels a sense of belonging and can thrive.,