Quality Assurance Specialist (Cell Therapy)

Cellipont; Research Forest (TX); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

401K match

Tuition reimbursement

Employee referral bonuses

Flexible work schedules

Paid time off

Job summary

Cellipont Bioservices is seeking a Quality Assurance Specialist to monitor GMP manufacturing processes on the floor, ensuring compliance and real-time QA support for cell therapies.

The role includes reviewing documentation, auditing processes, and guiding GMP operations within a dynamic team. Strong analytical and problem-solving abilities are essential, with flexibility for overtime as needed.

Qualifications

• Bachelor's Degree preferred with 2+ years GMP experience.
• Knowledge of manufacturing processes related to cell therapy.
• Analytical, troubleshooting, and decision-making skills.
• Ability to quickly learn new manufacturing processes for clients.
• Ability to work in a team setting and independently.

Responsibilities

• Perform QA on-the-floor activities supporting client projects, including room release and audits.
• Review batch records and supporting documentation for completeness and compliance.
• Lead root cause analysis using methods like fishbone, 5 whys, and comparative analysis.
• Write and revise GMP documentation; manage SOPs and related records.
• Participate in site and corporate quality and process improvement initiatives.
• Support evaluation and lot disposition of cell therapies.

Skills

Analytical skills

Troubleshooting

Decision making

Microsoft Access

Microsoft Excel

Microsoft Office

Database management

Record keeping

Education

Bachelor's degree in a related field

Tools

Electronic systems

Job description

Job Summary

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.

The Role

• • 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.

The Candidate

• • 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

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
• 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!"