QA Technician I, Operations

Job Description

Job Summary

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.

The Candidate

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)

Creative individual with excellent analytical, trouble shooting, and decision-making skills

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

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 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

Full-time