Sr. Quality Assurance Compliance Specialist, External Operations – 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.
We are seeking an individual to fulfill a role in the GMP External Operations Quality Assurance group. In this role, the employee will be responsible for packaging batch record review and support of product distribution. It includes review of master batch records, evaluation of deviations and temperature excursions, and creation or revision of supporting SOPs.
Executed batch record review for clinical and commercial packaging & labeling
Review of shipping temperature data
Cold Chain shipper qualification review
Create and edit quality agreements
Write and revise program SOP’s and associated Master Batch Records as required
Write, review, and manage related Quality Systems
Participate in external audits (CMO’s, packaging & labeling facilities)
Train and support other staff and consultants
Serve as a QA representative on teams as needed
Assist with additional projects as needed
BS degree or higher (preferably in Biology, Chemistry, or similar)
Minimum 5+ years QA GMP experience in the pharmaceutical/biotechnology industry
Direct QA experience with commercial DP packaging & labeling operations
Previous experience with writing Technical Quality Agreements
Experience in interactions with Contract Manufacturing Organizations a plus
Previous GMP auditing experience is a plus
Demonstrated ability to work in a team environment and manage projects independently
Excellent written and oral communication skills
Familiarity with FDA, EMA and ICH quality regulations
Proficient in MS Office applications
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 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.