This is a hybrid role working 2-3 days per week out of our Fort Lee, NJ office.

Job Summary

The Quality Specialist/Senior Specialist is primarily responsible for overseeing Kedrion Finished Products and managing the Kedrion Quality System. This role focuses on the development, implementation, management, and training of Standard Operating Procedures (SOPs) and controlled documents within MasterControl. Ensuring the quality and compliance of Kedrion Finished Products is paramount to this position, supporting Kedrion Quality Management System initiatives and driving continuous improvement.

Main Responsibilities

Product Distribution & Product Returns Management:

• Support product distribution releases to ensure timely and compliant delivery of product.

• Manage the product returns program, ensuring efficient processing and resolution of returned product.

• Oversee 3PL quality management systems, including handling returns, deviations, processes, repackaging, complaint handling, recalls, and counterfeit management.

• Collaborate with Kedrion Logistics to resolve Good Distribution Practice (GDP) issues for distributed products.

• Manage Kedrion and 3PL Good Manufacturing Practice (GMP) and GDP events, including temperature excursions assessment, change controls, quality incidents, deviations, complaints, returns, and product disposition.

Quality Assurance & Compliance:

• Support the Quality System at the Kedrion Fort Lee site, including investigations, Corrective and Preventive Actions (CAPA) processes, change controls, and risk assessments for quality events.

• Review and approve change controls, risk assessments, CAPAs, and quality investigations to ensure compliance and effectiveness.

• Oversee the management of controlled documents and SOPs life cycle, including internal procedure development and periodic reviews to meet Kedrion policies.

• Manage Quality Agreements with 3PLs, Contract Manufacturing Organizations (CMOs), and other Kedrion manufacturing sites.

• Support external audits for CMOs and 3PLs, ensuring CAPA effectiveness and compliance with regulatory requirements.

• Manage internal and external audits and inspections, ensuring readiness and compliance.

• Manage and support the Product Complaints Program, ensuring timely investigation and resolution of complaints.

• Serve as the Quality representative for day-to-day CMO and 3PL activities, providing guidance and support.

SOP and GxP Training Management:

• Manage the MasterControl Document and Training Management System, ensuring accurate and up-to-date documentation.

• Oversee training related to controlled documents and SOPs, ensuring all relevant employees are adequately trained.

• Maintain accurate records of training activities, ensuring that completion statuses are tracked and documented.

• Manage and maintain the Training Management Program to ensure GxP compliance and alignment with job functions.

• Organize and coordinate training for new and updated documents, ensuring that all relevant employees are trained as required.

Education, Qualifications & Experience

• Bachelor's degree in Pharmaceutical Manufacturing/Science, Chemistry, Biology, or a related field.

• Minimum of 5 years of cGMP experience in the pharmaceutical industry, with expertise in product releases and distribution.

• Hands-on experience with GMP Quality Systems, including knowledge of biologics and sterile product manufacturing.

• Excellent verbal and written communication skills, with the ability to convey complex information clearly and concisely.

• Proven ability to work collaboratively in a team environment and make independent decisions when necessary.

• Experience in project management and continuous improvement initiatives, demonstrating a proactive approach to problem-solving.