QA Technician I, Operations

Cellipont Bioservices • The Woodlands, TX

1d

About The Position

Cellipont Bioservices is growing, and we are looking for a QA Technician I, Operations who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The QA Technician I, Operations will be responsible for monitoring systems and procedures to ensure compliance where applicable. The QA Technician I, Operations is responsible for providing Quality Assurance support real-time for GMP Manufacturing of Cell Therapies. This individual will be responsible for providing QA on the Floor during manufacturing including observing critical processes, review executed GMP documentation, and supporting other QA functions as needed. The Role Performs QA On-the-Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and escalating issues that occur during manufacturing. Perform inspections of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices. Review executed batch records, supporting documentation and logbooks for completeness, accuracy and compliance. Act as first responder for on the floor quality issues in a timely manner, documentation of all deviations and required immediate corrective actions. Support the evaluation and lot disposition of cell therapies Perform Acceptable Quality Limit (AQL) visual inspection of drug product Participate in site quality and process improvement initiatives. Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

Requirements

• Bachelor's Degree preferred with a minimum of 0-1 years of direct GMP industry experience
• Knowledgeable and/or exposure related to biological manufacturing (preferably Cell Therapy)
• Cr e a t i v e indi v idua l w i th ex c e ll e n t analytical, t r o ubl e s h o o t in g, and decision-making sk il l s
• Ability to quickly learn new and novel manufacturing processes supporting new clients
• Able to work in a team setting and independently under minimum supervision
• Familiarity with electronic systems, including developing and producing reports using Microsoft Access and Excel
• Intermediate knowledge of Microsoft Office and database management skills, organization, and record keeping skills required.
• Ability to function well in a changing environment

Responsibilities

• Performs QA On-the-Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and escalating issues that occur during manufacturing.
• Perform inspections of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
• Review executed batch records, supporting documentation and logbooks for completeness, accuracy and compliance.
• Act as first responder for on the floor quality issues in a timely manner, documentation of all deviations and required immediate corrective actions.
• Support the evaluation and lot disposition of cell therapies
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Participate in site quality and process improvement initiatives.
• Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

Benefits

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of 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
• PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 11-50 employees