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Senior Quality Control Analyst

2 months ago

Spring Hills, Texas, United States Cellipont Bioservices Full time
Job Overview

Position Summary

Cellipont Bioservices is expanding, and we are seeking a Quality Control Lead Analyst who is passionate about transforming client innovations into therapeutic solutions and is eager to elevate Cellipont and its partners to new heights.

The Quality Control Lead Analyst operates in a dynamic setting, supporting the quality assurance division of a Contract Development and Manufacturing Organization (CDMO) focused on cell therapy production. This role entails routine testing, assay transfer, and validation, preparation and revision of quality control documentation (SOPs/Protocols/Reports), conducting laboratory investigations, and maintaining laboratory environments.

Additionally, the Quality Control Lead Analyst is accountable for executing all tasks efficiently and economically to guarantee satisfaction for clients and stakeholders. This position also demands a strong capacity for cross-functional collaboration and exceptional leadership capabilities.

Key Responsibilities

  • Conduct routine and in-process evaluations for cell therapies and raw materials in accordance with departmental SOPs.
  • Utilize technical expertise to ensure compliance in all testing procedures.
  • Support method transfers, qualifications, validations, and routine evaluations of in-process, final products, or stability samples.
  • Draft, review, and/or approve SOPs, testing methodologies, material specifications, and other essential QC laboratory procedures.
  • Analyze data in compliance with established protocols and cGMP standards.
  • Set up and manage quality control instruments, including cell counters, centrifuges, and biological safety cabinets, while coordinating maintenance with facility staff.
  • Proactively identify and resolve issues in daily operations or testing processes. Communicate effectively with management regarding task completion, challenges, and requirements.
  • Maintain the QC laboratory and manage inventory.
  • Assist in the training and mentoring of new personnel. Become a certified trainer on designated assays and provide training to analysts, documenting training in accordance with procedural and cGMP standards.
  • Support investigations of deviations and out-of-specification results, compiling relevant data and information as necessary.
  • Coordinate with external or third-party testing laboratories regarding testing and turnaround times for results.
  • Work autonomously in a fast-paced team environment, meeting deadlines and prioritizing tasks across multiple projects.
  • Communicate effectively with cross-functional colleagues, departmental management, and other stakeholders as required.

Candidate Qualifications

  • Bachelor's degree in Life Sciences with a minimum of 3 years of relevant industry experience, or an Associate's degree in Life Sciences with at least 5 years of relevant industry experience.
  • Self-motivated individual capable of delivering results in a fast-paced environment while meeting client deadlines with minimal supervision.
  • Practical experience with various analytical techniques, including ELISAs, cell counting, flow cytometry, cell culture, and/or PCR (qPCR or ddPCR).
  • Hands-on experience with analytical method transfers, qualifications, and validations.
  • Experience with compendial method verifications is advantageous.
  • Familiarity with system management is a plus.
  • Technical expertise in flow cytometry is beneficial.
  • Understanding of cGMP, ICH, and FDA regulations.
  • Excellent verbal and written communication skills.

Benefits of the Position

  • Opportunities for professional advancement within a growing team.
  • Clearly defined career progression and an annual performance review process.
  • Exposure to various functions within the organization.
  • Comprehensive benefits package tailored to unique health and wellness needs, including coverage for pets.
  • Strong employer match for 401K contributions.
  • Tuition reimbursement programs.
  • Employee referral bonuses.
  • Flexible work schedules and paid time off, increasing one PTO day each year, along with paid holidays.
  • Experience in the innovative field of cell therapy.

At Cellipont Bioservices, we value candidates who possess a genuine desire to serve. Our familial approach ensures you receive the mentorship necessary for a fulfilling career.


Notice to Agency and Search Firm Representatives

Cellipont Bioservices does not accept unsolicited resumes from agencies or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position due to an unsolicited agency or search firm referral. Thank you.