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Quality Control Lead Specialist

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 Specialist who is passionate about transforming scientific discoveries into effective patient treatments and is eager to innovate and elevate both Cellipont and its clients.

The Quality Control Lead Specialist operates in a dynamic setting, supporting the quality assurance division of a Contract Development and Manufacturing Organization (CDMO) focused on cell therapy production. Responsibilities include conducting routine analyses, facilitating assay transfers, validating assays, preparing and revising quality control documentation (SOPs/Protocols/Reports), managing laboratory investigations, and overseeing laboratory setup and upkeep.

This role demands timely and cost-effective execution of all tasks to ensure satisfaction for customers and stakeholders. The individual must exhibit strong cross-functional collaboration and leadership capabilities.

Key Responsibilities

  • Conduct routine and in-process testing for cell therapies and raw materials according to departmental SOPs.
  • Utilize technical expertise to ensure compliance in all testing procedures.
  • Support method transfers, qualifications, validations, and routine testing of in-process, final product, or stability samples.
  • Draft, review, and/or approve SOPs, testing methods, material specifications, and other necessary procedures for QC laboratory operations.
  • Analyze data in accordance with established procedures and cGMP standards.
  • Set up and operate quality control instruments, including cell counters, centrifuges, and biosafety cabinets, while coordinating maintenance with facility staff.
  • Proactively identify and resolve issues in daily operations or testing processes. Communicate effectively with management regarding task progress, challenges, and requirements.
  • Maintain the QC laboratory and manage inventory.
  • Assist in training and mentoring new personnel, becoming a qualified trainer for assigned assays and documenting training in line with procedural and cGMP standards.
  • Support investigations of deviations and out-of-specification results, compiling necessary data and information for internal inquiries.
  • Follow up with external testing laboratories regarding testing timelines and results.
  • Work autonomously in a fast-paced team environment, meeting deadlines and prioritizing tasks across multiple projects.
  • Effectively communicate with cross-functional colleagues, departmental management, and other stakeholders as needed.

Candidate Profile

  • 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 experience.
  • Self-motivated individual capable of delivering results in a fast-paced environment 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.
  • Strong verbal and written communication skills.

Benefits of the Position

  • Opportunities for professional growth within a developing team.
  • Defined career progression and annual performance evaluations.
  • Exposure to various functions within the organization.
  • Comprehensive benefits package tailored to unique health and wellness needs, including coverage for pets.
  • 401K with a strong employer match.
  • Tuition reimbursement programs.
  • Employee referral bonuses.
  • Flexible work schedules and paid time off, increasing by one 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 contribute. Our supportive environment ensures you receive the mentorship necessary for a fulfilling career.