Manufacturing Documentation Specialist Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack applies its systems biology-based approach to biomedical research throughout the research and development process. Merrimack currently has six oncology therapeutics in clinical development.
We are seeking a highly motivated individual to join our manufacturing process operations team. The ideal individual will have experience in cGMP manufacturing and documentation practices with excellent communication skills and the ability to work in a cross-functional team environment. The Manufacturing Documentation Specialist will be a close liaison with the QA, QC, and Supply Chain groups to ensure that manufacturing receives the necessary support from those teams. The Specialist will complete documentation tasks required for successfully closing out production campaigns and allowing product disposition.
Requesting, organizing, revising, and reviewing executed batch records for accuracy and cGMP compliance;
Closing production campaigns by creating reports, approving records executed, identifying deviations and addressing quality incidents; closing out CAPA?s, assisting and launching investigations to determine route cause of deviations and batch termination;
Responsible for on-the-floor, timely and effective GMP review of batch records and logbooks;
Ensuring all GMPs, SOPs, policies and protocols are followed;
Ensuring corrective actions are completed within set timeline including revision of SOPs, MBRs, training of personnel;
Identifying and correcting gaps in documentation, as well as current practices, to meet GMP standards and objectives.
BS degree in science with 5 years of related GMP manufacturing or quality experience in the biotechnology/pharmaceutical industry;
Prior experience with batch record review is a must;
Strong background and skills in process unit operations (cell culture, protein purification, solution preparation, etc.), auditing, communication and computer related systems;
Must be well organized, flexible and work with minimal supervision;
Batch Record Coordinator experienced with Deviation Investigations and Root Cause Analysis;
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139
THIS JOB HAS EXPIRED