QA Compliance Specialist Merrimack Pharmaceuticals
THIS JOB HAS EXPIRED Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has six targeted therapeutic oncology candidates in clinical development.
This position is responsible for providing overall support for drug substance manufacturing activities and ensuring compliance with applicable GMP regulations. This role will perform manufacturing batch record review as well as review of all GMP documentation that supports the manufacturing operation.
Perform manufacturing batch record review to support disposition of clinical products.
Disposition Raw Materials for use in GMP Manufacturing
Review supporting documentation such as equipment logs, activity logs, and work orders
Initiate and/ or assist departments with investigations related to manufactured products
Assure that manufacturing operations are in compliance with GMP regulations
BS degree or higher (preferably in Biology or Chemistry)
Minimum 2+ years of Quality Assurance (GMP) experience in the pharmaceutical/biotechnology industry
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
Proficient in MS Office applications
Experience with review and approval of GMP documentation such as Executed Batch Records and SOPs
Ability to demonstrate high personal work standards and a sense of urgency about results; do everything possible to meet goals and deadlines; persist in the face of repeated challenges; accept responsibility for the outcomes of his/her own work
Ability to review documents for accuracy and consistency; able to take action to prevent mistakes, can follow procedures closely; keep records accurate and up to date.
Ability to be open to creative ideas suggested to solve problems and improve work methods; apply novel approaches to situations; collaborate with team members to brainstorm creative approaches; rethink situations to create new opportunities or overcome obstacles.
Ability to establish personal standards of quality from own work processes, products and/or services; identify and apply 'best practices' in own work; improve the efficiency of own works by eliminating barriers and streamlining work processes; measure and track own performance.
Ability to earn trust and credibility by completing own share of the team's work; place team priorities above own personal agenda; appropriately consider other's opinions on matters that affect the team. Challenge proposed actions in a way that facilitates constructive discussion; support team decisions, even if different from own opinion.
||One Kendall Square |
Building 700, Second Floor
Cambridge, MA 02139
THIS JOB HAS EXPIRED