Senior QA Specialist, Cell Therapy GMP

Cellipont Bioservices; The Woodlands (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

401K strong employer match

Tuition Reimbursement

Flexible work schedules

Employee Referral Bonuses

Career growth opportunities

Job summary

A biotechnology company in The Woodlands, Texas is seeking a Senior QA Specialist to ensure compliance with quality standards in cell therapies. This role entails coordinating batch release, reviewing GMP documentation, and serving as the QA point of contact for clients. Candidates should possess a Bachelor's Degree in a Life Science discipline and 4-6 years of relevant experience in pharmaceuticals. The position offers opportunities for career growth and a robust benefits package. Interested candidates should be self-starters who thrive in a fast-paced environment.

Qualifications

• 4-6+ years' quality experience within pharmaceuticals, strong preference for biologics or advanced therapeutics.
• Hands-on experience with analytical method transfers, qualifications, and validations.
• Ability to meet client deadlines under minimal supervision.

Responsibilities

• Coordinate batch release and ensure compliance with regulatory standards.
• Review and approve GMP documentation.
• Act as QA point of contact for clients and interact through various methods.

Skills

Quality experience

Analytical method transfers

cGMP/ICH/FDA regulations

Excellent communication skills

Self-starter

Education

Bachelors Degree in Life Science

Job description

A biotechnology company in The Woodlands, Texas is seeking a Senior QA Specialist to ensure compliance with quality standards in cell therapies. This role entails coordinating batch release, reviewing GMP documentation, and serving as the QA point of contact for clients. Candidates should possess a Bachelor's Degree in a Life Science discipline and 4-6 years of relevant experience in pharmaceuticals. The position offers opportunities for career growth and a robust benefits package. Interested candidates should be self-starters who thrive in a fast-paced environment.