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.

The Role

• 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

The Candidate

• 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

POSITION BENEFITS

• 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

"At Cellipont Bioservices, 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!"

Notice to Agency and Search Firm Representatives

Cellipont Bioservices does not accept unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral.