Lead Specialist, QA (Contractor)

How you’ll make an impact:

We are looking to add to our team of innovators, disruptors, and caregivers. This role will play a pivotal part in how we deliver more than just treatment to our patients; it will enable us to deliver hope.

About the team:

The internal QA Operations Team oversees resolution of quality issues encountered with in-process and lot release testing, and stability testing performed both in our internal GMP QC Testing Laboratory, and at our CTO’s, as well as supports the Stability, QSAT and Critical Reagents teams with protocol and report generation. There will be external relationship and communication needed to support efficient and compliant processes and program management.

How you’ll spend your time:

Support 2seventy bio Stability program and GMP Testing Laboratory (GTL) Cambridge operations
Management of data review, analysis, identification of trends, and complex problem solving.
Review and approve documents including testing, method validation, stability and qualification protocols and reports, lab investigations, retest plans, deviations, expiration extensions and supporting trend analyses, and change controls.
May be called on to assist in manufacturing batch record review and review of internal documentation and forms in support of product lot release.
Prepare and review documentation associated with deviations, investigations, OOS results, and CAPA action plans.
Ensure all documentation complies with cGMP regulations and industry guidelines.
Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
Engage in activities to continuously assess and improve Quality processes.
Support the development, implementation, and revision of corporate quality systems.
Who you are and what you’ve accomplished:

Who you are and what you’ve accomplished:

This role is at the Lead Specialist level.

BA/ BS and a minimum of 6 years in Quality Assurance and/or Quality Control, including experience with quality control laboratory oversight. Previous QC Lab or Stability program oversight experience and/or support highly desired
Experience and/or knowledge of cellular therapy collection, processing, and upstream manufacturing beneficial, but not required
Experience and/or knowledge of QC biopharmaceutical testing, cell-based assays, stability program management are all pluses.
Experience with deviation investigations, OOS lab investigations, change control, CAPA development and process improvements
Knowledge of GxP regulations, quality systems, and quality control program guidance documents (including ICH Q1A, ICH Q1B, ICH Q1C, ICH Q1D, ICH Q1E, ICH Q5C, ICH Q5D, WHO, and FDA CBER Guidance)
Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities and multiple stakeholders
Experience interacting with external vendors, contract testing organizations, including identifying, communicating, and resolving complex issues
Experience with impact and risk assessment tools, process mapping and process improvement tools
Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view