Senior QA Specialist – Cell Therapy, Growth & Flexible PTO

Cellipont Bioservices; Silver Spring (MD); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Career growth

Cross-functional exposure

Health & Wellness benefits

401K matching

Tuition Reimbursement

Flexible work schedules

Job summary

Cellipont Bioservices is seeking a Senior QA Specialist to join the Quality Operations team. The role covers batch disposition, real-time tracking, and ensuring compliance with cGMP standards for cell therapies from benchtop to bedside.

You will produce and approve GMP documentation, lead investigations, and coordinate with cross-functional groups and clients. Strong communication and regulatory knowledge are essential in this fast-paced, growing biotech environment.

Qualifications

• Bachelor's Degree in Life Science.
• 4-6+ years quality experience in pharmaceuticals, strong preference for biologics or advanced therapeutics.
• Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
• Hands-on experience with analytical method transfers/qualifications/validations.
• Hands-on experience with early, late, and commercial manufacturing process transfers/qualifications/validations.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.
• Must be available to work occasional weekend or holiday support as needed.

Responsibilities

• Disposition of batches and real-time tracking.
• Prepare final disposition packages for QA.
• QA point of contact for clients via Teams, email, and in-person meetings.
• Write, revise and approve GMP documentation.
• Review validations, qualifications, risk assessments, and testing methods.
• Ensure that Quality requirements are met and documented for the product lifecycle per procedures and regulatory requirements.
• Perform internal audits and lead root-cause analysis.

Skills

Quality Assurance

GMP Compliance

cGMP

Documentation

Audits

Education

Bachelor's degree in Life Science

Job description

Cellipont Bioservices is seeking a Senior QA Specialist to join the Quality Operations team. The role covers batch disposition, real-time tracking, and ensuring compliance with cGMP standards for cell therapies from benchtop to bedside.

You will produce and approve GMP documentation, lead investigations, and coordinate with cross-functional groups and clients. Strong communication and regulatory knowledge are essential in this fast-paced, growing biotech environment.