Quality Assurance Specialist (Cell Therapy)

Cellipont Bioservices • The Woodlands, TX

18h

About The Position

Cellipont Bioservices is growing, and we are looking for a Quality Assurance Specialist 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 Quality Assurance Specialist will be responsible for monitoring systems and procedures to ensure compliance where applicable. The Quality Assurance Specialist 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.

Requirements

• Bachelor's Degree preferred with a minimum of 2+ years of direct GMP industry experience
• Knowledgeable and/or exposure manufacturing processes related to 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.
• Clear problem-solving and decision-making skills
• Ability to function well in a changing environment and work overtime occasionally and on weekends as needed

Responsibilities

• Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
• Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance.
• Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
• Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
• Support the evaluation and lot disposition of cell therapies.
• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product.
• Write and revise GMP documentation as necessary.
• Accountable for administration and tracking of Standard Operating Procedures (SOPs).
• Participate in site and corporate 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
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level