Senior Quality Assurance Specialist

Bridging Innovation to Cure "Developing and manufacturing your cell therapies from benchtop to bedside"

Summary The Senior QA Specialist is a key member of the Quality Operations function. Within the Quality Operation function these individual responsibilities would include, batch release coordination, , review and approval of deviations, and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of cell therapies. This position plays a key role demonstrating the values, culture and deliverables for the site.

Responsible for all aspects of batch disposition for designated client programs including real-time tracking of batch and documentation, cross-functional development of release timelines, communication of timelines and progress both internally and externally

Responsible for ensuring all documentation required for batch disposition is in the appropriate state for the level of disposition and providing the final disposition package to QA management for final disposition decision

Responsible for being the QA point of contact for assigned clients and interacting with clients on a frequent basis through a variety of methods including Microsoft Teams video meetings, email communication, and in-person meetings

Write, revise and approve GMP documentation as necessary including, but not limited to, SOPs, and specifications

Review and approve validations, qualifications, risk assessments, and testing methods

Ensure that Quality requirements are met and appropriately documented for the product lifecycle according to procedures and regulatory requirements

Perform internal audits

Act as first responder for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.

Act as QA reviewer for investigations, deviations and CAPA; as designated by QA Management

Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

Works cross-functionally with Project Management, Manufacturing, Facilities, MS&T, Development and Quality Control in meeting project deliverables in a compliant and efficient manner

Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary

Actively participates in client audits

Provide training to more junior personnel within the team

Consistent vigilance for opportunities for improvement and championing those opportunities to closure

Perform additional duties as assigned

Bachelors Degree in a Life Science discipline

4-6 yrs.+ years' quality experience within pharmaceuticals, strong preference for biologics or advanced therapeutics

Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision

Hands-on experience with analytical method transfers/qualifications/validations

Hands-on experience with early, late, and commercial manufacturing process transfers/qualifications/validations

Knowledge of cGMP/ICH/FDA regulations

Excellent oral and written communication skills

Must be available to work occasional weekend or holiday support as needed

Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Ability to work off-shift and extra hours as required which may include weekends and holidays as required

Opportunities for career growth within an expanding team Defined career path and annual performance review & feedback process

Cross-functional exposure to other areas within the organization

Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
401K strong employer match

Tuition Reimbursement Employee Referral Bonuses Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays

Gain experience in the cutting-edge cell therapy space

We look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here!