Apply on Employer Site

CTMC · 1 week ago

QA Specialist IV, Quality Assurance Operations

Houston, TX

Full-time

Onsite

Senior Level

5+ years exp

CTMC is a pioneering biotech joint venture formed by National Resilience and MD Anderson Cancer Center, focused on accelerating cell therapies from bench to bedside. The QA Specialist IV will be responsible for reviewing and approving QC test results, investigating deviations, and ensuring compliance with laboratory practices and regulations.

BiopharmaBiotechnologyTherapeutics

H1B Sponsor Likely

Hiring Manager

Jenifer Klemme

Responsibilities

Review and approve QC test results, laboratory records, and batch analysis documentation

Investigate QC-related deviations, OOS/OOT results, and non-conformances. Participate in root-cause analysis and develop CAPA actions

Review, evaluate, and approve change control requests impacting QC processes or systems

Review and support method validation, method verification, and transfer documentation

Review equipment qualification records (IQ/OQ/PQ) and calibration documents

Conduct internal audits of QC laboratories and follow up on corrective actions

Assist with external audits by regulatory authorities and customers

Ensure data integrity and laboratory compliance with electronic systems (LIMS, ELN, etc.)

Support disposition/ Hold/ Rejection of raw materials

Partner with other departments to implement, optimize, review, and approve quality control records, practices, and procedures

Participate in audits when needed

Other duties as required

Qualification

Quality Control experienceCGMPsCellGene TherapiesLIMS systems experienceRegulationsAnalytical skillsMicrosoft Office proficiencyVerbal communication skillsWritten communication skillsInterpersonal skillsOrganizational skillsAttention to detailTime management skillsProblem-solving skills

Required

Bachelor's degree in a scientific field required

5+ yrs in Quality Assurance/Quality Control within the field or an equivalent combination of education and experience

Quality Control experience required

Understanding of Cell and Gene Therapies

Understanding of cGMPs, GLPs and GXPs

Previous experience with LIMS systems (preferable LabVantage experience)

Knowledge of local and global regulations

Verbal and written communication skills

Interpersonal and customer service skills

Organizational skills and attention to detail

Time management skills with a proven ability to meet deadlines

Analytical and problem-solving skills

Proficient with Microsoft Office Suite or related software

Company

CTMC

CTMC is a clinical cancer center to enable innovation from academia and biotech to accelerate cell therapy’s impact on cancer patients.

Founded in 2022

Houston, Texas, USA

51-200 employees

https://ctmc.com

H1B Sponsorship

CTMC has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)

2022 (1)