QC Analyst I, Analytical

Cellipont Bioservices • The Woodlands, TX

2d

About The Position

Cellipont Bioservices is growing, and we are looking for a QC Analyst I, Analytical 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 QC Analyst I, Analytical will work in a fast-paced environment supporting the quality control department of a CDMO for manufacturing of cell therapies. The QC Analyst I, Analytical will be responsible for routine testing, assay transfer and assay validation, QC document preparation and revision (SOPs/Protocols/Reports), as well as support for laboratory setup and maintenance.
The QC Analyst I, Analytical, will also be responsible for ensuring all activities are executed timely and cost effectively to ensure customer and stakeholder satisfaction. This role will also require the individual to demonstrate a strong ability to work cross-functionally and possess strong leadership skills.

Requirements

• Bachelors Degree preferred in Life Sciences discipline with 0-1 years of relevant experience.
• 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 compendial method verifications.
• Knowledge of cGMP/ICH/FDA regulations.
• Excellent oral and written communication skills.

Nice To Haves

• Hands-on experience with system management is a plus.
• Technical background and expertise in flow cytometry is a plus.

Responsibilities

• Assist in the performance of routine and in process testing for drug substance/drug product as well as raw materials, per departmental SOPs, as required.
• Provide support for method transfers/qualification/validation and routine testing of in-process, final product, or stability samples.
• Operate quality control equipment, including cell counters, centrifuges, BSCs and coordinates maintenance of this equipment with facility personnel.
• Maintains QC laboratory and inventory.
• Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Communicate effectively with cross-functional peers, department management, and other partners as needed.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level