Job Summary
Cellipont Bioservices is growing, and we are looking for a QC Analyst II, 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 II works in a fast-paced environment supporting the quality control department of a CDMO for manufacturing cell therapies. The Senior QC Analyst will be responsible for routine testing, assay transfer, assay validation, QC document preparation and revision (SOPs/Protocols/Reports), as well as support for laboratory setup and maintenance.
The QC Analyst II is also 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.
The Role
- Independently perform routine and in-process testing for cell therapies 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.
- Author, review, and/or approve SOPs, test methods, material specifications, and other procedures required to operate a QC laboratory.
- Review data following applicable procedures and cGMP requirements.
- Set up and operate quality control equipment, including cell counters, centrifuges, BSCs, and coordinate maintenance of this equipment with facility personnel.
- Maintain QC laboratory and inventory.
- Expertise with various analytical techniques, including ELISAs, cell counting, flow cytometry, cell culture, and/or PCR (qPCR or ddPCR).
- 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.
The Candidate
- B.S. in a Life Sciences discipline or A.S. with 2 years of direct industry 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.
- Hands-on experience with system management is a plus.
- Technical background and expertise in flow cytometry is a plus.
- Knowledge of cGMP/ICH/FDA regulations.
- 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.
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