Senior Quality Assurance Compliance Specialist – Merrimack Pharmaceuticals – Cambridge, MA, USA
Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack’s first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection; Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack’s website at www.merrimack.com or connect on Twitter at @MerrimackPharma.
This position is responsible for the quality oversight of GMP Manufacturing Operation activities and/ or Quality Control daily activities at Merrimack. The successful candidate will support daily manufacturing activities in both commercial and clinical settings. The candidate should be expected to leverage training, experience and technical knowledge to manufacturing and/or QC and support groups on a routine basis, influencing a fast-paced dynamic environment to address quality concerns appropriately. This includes appropriate interpretation and use of existing quality systems and practices.
In addition, the candidate will be asked to support other vital QA areas such as training, validation, QC, and facilities as required.
Job Responsibilities:
Leads, Interfaces and influences cross-functionally in GMP areas such as Manufacturing and/or QC areas to continually improve quality at Merrimack
Perform real-time batch record reviews as assigned
Train lower level QA Specialists on basic QA Systems (batch record review, product changeover, QIs, etc) to support GMP areas as needed
Support quality systems QI(deviation), CAPA, Change Control, Environmental Monitoring, etc to support lot release and continuous improvement
Working with key stake holders Initiate and support the closure of the above Quality Systems documents, prepare lot packets with all the appropriate Quality System documents for the disposition process
Resolves manufacturing issues as they arise in an efficient, effective, and collaborative manner
Performs walkthroughs and audits as required
Supports additional QA tasks or participates in projects as assigned Participate on various project teams as assigned
Review and approve COA (Certificate of Analysis)
Review and approve all levels for QIs as assigned
Review and approve of Work Orders, SOPs, and validation protocols and reports as assigned
Review and approve QC method validations, OOSs, OOTs, Stability protocols, QC logbook review and other activities to support QC as assigned
Requirements:
BS degree or higher (preferably in Biology or Chemistry)
Minimum 7+ years Quality Assurance GMP experience in the pharmaceutical/ biotechnology industry (commercial experience preferred)
Excellent written and oral communication with exceptional organization and multitasking ability
Demonstrated ability to work in a team environment as well as manage projects independently
A thorough understanding of FDA, EMA and ICH quality regulations
Proficient in MS Office applications and electronic document management
Experience in aseptic processing, monoclonal antibody production or nanoliposomal drug manufacturing is a plus
All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.
