QC Senior Specialist, Raw Materials

Job Summary

Cellipont Bioservices is growing, and we are looking for a QC Sr Specialist, Raw Materials 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 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 QC Sr Specialist, Raw Materials will be responsible raw material specification review and approval, drafting/approval of raw material sampling plan and risk assessments, as well as coordinating raw material qualification program for commercialization of cell therapy products.

The QC Sr Specialist, Raw Materials is also responsible for ensuring all activities are executed timely and and cost effectively to ensure customer and stakeholder satisfaction. This role will also require the individual to demonstrate strong ability to work cross-functionally and possess strong leadership skills.

The Role

• Lead QC activities associated with incoming raw material life cycle management, including new material assessment, drafting/approval of raw material specifications and sampling plans.
• Performs testing of incoming raw materials and components according to specifications and procedures.
• Performs 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. Assesses and executes 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.

The Candidate

• BS or A.S in a Life Sciences discipline with a minimum of 4 years of relevant GMP industry experience.
• Previous experience working in groups which support receipt, inspection, or release or materials in a pharmaceutical or biotechnology facility is a plus.
• Familiarity with USP and EP pharmacopeias, and pharmaceutical raw material compendial testing.
• Knowledge and 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 under 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 & 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