QA Technician II, Operations

Cellipont; Research Forest (TX); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health & Wellness benefits

Pet coverage

401(k) match

Tuition reimbursement

PTO & holidays

Employee referral bonuses

Job summary

Cellipont Bioservices is seeking a QA Technician II, Operations to monitor GMP manufacturing activities, review documentation, and support on-floor quality initiatives to safeguard product quality.

The role involves audits, batch record review, real-time QA support, root-cause analysis, and guidance to teams on cGMP compliance, processes improvements, and adherence to internal procedures.

Qualifications

• Bachelor's Degree preferred with 1–2 years of GMP industry experience.
• Knowledge of cell therapy manufacturing processes is a plus.
• Strong analytical, troubleshooting, and decision-making skills.

Responsibilities

• On-floor QA activities supporting client projects, including room release and process audits.
• Review real-time documentation and resolve manufacturing issues.
• Audit manufacturing and support areas and review batch records for compliance.
• Respond to on-floor quality issues and initiate corrective actions.
• Participate in root cause analysis and support lot disposition of cell therapies.
• Perform AQL visual inspections and update GMP documentation as needed.
• Contribute to quality/process improvement initiatives and train staff.

Skills

QA on-floor

Analytical skills

Troubleshooting

Decision-making

Team collaboration

Documentation proficient

Microsoft Office

Microsoft Excel

Microsoft Access

Education

Bachelor's Degree

Tools

Microsoft Access

Excel

Job description

Job Summary

Cellipont Bioservices is growing, and we are looking for a QA Technician II, Operations who believes in the potential of bridging clients' 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 II, Operations will be responsible for monitoring systems and procedures to ensure compliance, providing real‑time Quality Assurance support for GMP Manufacturing of master/working cell banks, and overseeing manufacturing on the floor, including observing critical processes, performing AQL visual inspections, reviewing GMP documentation, and supporting other QA functions as needed.

The Role

• Performs QA on‑floor activities supporting client projects, including room release, auditing critical processes, reviewing real‑time documentation, and resolving manufacturing issues.
• Performs audits of manufacturing and support areas, including in‑process batch record review for adherence to internal procedures and industry best practices.
• Reviews and disposes of executed batch records and supporting documentation for completeness, accuracy and compliance.
• Acts as first responder for on‑floor quality issues in a timely manner, documents all events/investigations and initiates immediate corrective actions.
• Participates in root cause analysis using methodologies such as fishbone, 5‑whys and comparative analysis.
• Supports the evaluation and lot disposition of cell therapies.
• Performs AQL visual inspection of drug product.
• Writes and revises GMP documentation as necessary.
• Participates in site and corporate quality and process improvement initiatives.
• Guides personnel directly and indirectly involved in GMP operations regarding cGMP compliance, internal procedures, regulatory requirements and industry best practices.

The Candidate

• Bachelor's Degree preferred with a minimum of 1–2 years of direct GMP industry experience.
• Knowledgeable and/or exposed to manufacturing processes related to cell therapy.
• Creative individual with excellent analytical, troubleshooting, and decision‑making skills.
• Ability to quickly learn new and novel manufacturing processes supporting new clients.
• Ability 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, and strong organization and record‑keeping abilities.
• Clear problem‑solving and decision‑making skills.
• 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 and feedback process.
• Cross‑functional exposure to other areas within the organization.
• Robust benefit package designed for unique Health & Wellness needs, including coverage for furry family members.
• 401(k) with strong employer match.
• Tuition reimbursement.
• Employee referral bonuses.
• Flexible work schedules and PTO based on role/level, increasing one PTO day each year and paid holidays.
• Gain experience in the cutting‑edge cell therapy space.