QC Senior Specialist, Raw Materials(W)

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

Benefits offered by this job

Career growth opportunities

401K employer match

Tuition reimbursement

Flexible work schedules

Job summary

Cellipont Bioservices is hiring a QC Sr Specialist, Raw Materials in The Woodlands, Texas. This role involves leading quality control activities related to raw materials, ensuring compliance with specifications, and managing qualification programs for cell therapy products.

The ideal candidate should have a BS or A.S in Life Sciences and at least 4 years of GMP industry experience. Opportunities for career growth and a robust benefits package are offered, along with flexible work schedules and PTO.

Qualifications

• 4+ years of GMP industry experience in the pharmaceutical or biotech field.
• Experience supporting receipt, inspection, and release of materials.
• Familiarity with pharmaceutical raw material compendial testing.

Responsibilities

• Lead QC activities for raw material life cycle management.
• Perform testing of incoming raw materials.
• Conduct routine investigations for out of specification results.
• Manage raw material qualification programs.
• Coordinate outsourced testing with contract testing labs.
• Support quality systems related to raw material investigations.

Skills

GMP industry experience

Scientific principles application

Excellent communication skills

FDA regulations knowledge

Education

BS or A.S in Life Sciences

Job description

Overview

Cellipont Bioservices is growing, and we are looking for a QC Sr Specialist, Raw Materials who believes in 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 QC Sr Specialist, Raw Materials works in a fast-paced environment providing quality control support for the receipt of raw materials, as well as raw material documentation and qualification. The role includes raw material specification review and approval, drafting/approval of raw material sampling plans and risk assessments, and coordinating raw material qualification programs for commercialization of cell therapy products. The role requires ensuring all activities are executed timely and cost effectively to ensure customer and stakeholder satisfaction, and demonstrates cross-functional collaboration and leadership skills.

Responsibilities

• Lead QC activities associated with incoming raw material life cycle management, including new material assessment, drafting/approval of raw material specifications and sampling plans.
• Perform testing of incoming raw materials and components according to specifications and procedures.
• Conduct routine investigations in support of out of specification testing results.
• Manage raw material qualification program for raw materials in a phase-dependent manner.
• Coordinate outsourced testing and sample shipments with contract testing laboratories CTLs if required.
• Support quality systems associated with raw material investigations, deviations, and/or CAPAs. Assess and execute actions related to change controls and vendor change notifications, as pertains to QC.
• Assist in drafting and approval of raw material risk assessments, as required.
• Maintain and evaluate raw materials processes and procedures. Identify and initiate opportunities for continuous improvement.

Qualifications

• BS or A.S in a Life Sciences discipline with a minimum of 4 years of relevant GMP industry experience.
• Experience in groups supporting receipt, inspection, release of materials in a pharmaceutical or biotechnology facility is a plus.
• Familiarity with USP and EP pharmacopeias and pharmaceutical raw material compendial testing.
• Ability to apply basic scientific principles to solve operational and quality tasks.
• Knowledge of FDA regulations is a plus.
• Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines with minimal supervision.
• Excellent oral and written communication skills.

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 health and wellness needs
• 401K 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