Quality Assurance Specialist II or III - March Biosciences

BioHouston; Houston (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading clinical-stage cell therapy company seeks a detail-oriented Quality Assurance Specialist II or III in Houston. This pivotal role involves ensuring compliance with regulatory standards, maintaining product integrity, and driving continuous quality improvement. Ideal candidates should have a scientific degree and substantial experience in pharmaceutical quality assurance.

Qualifications

• 3-5 or 5–7 years of experience in pharmaceutical QA or GMP-regulated environment.
• Strong knowledge of cGMP, ICH guidelines, and applicable FDA regulations.

Responsibilities

• Lead executed manufacturing and testing document review and Final Product release.
• Collaborate with cross-functional teams to resolve quality issues.
• Provide quality review of documents including SOPs and reports.

Skills

Attention to detail

Problem-solving

Quality assurance

Education

Bachelor’s degree in a scientific discipline

Tools

Document management systems

Quality management software

Job description

Job title: Quality Assurance Specialist II or III

Location: Houston, TX

About March Biosciences

March Biosciences, Inc is a clinical-stage cell therapy company with a mission to transform patient care in the most challenging hematological malignancies. March Bio’s lead asset is at the end of Phase I trials for T-cell malignancies, diseases with a dismal prognosis that is currently unaddressed by CAR-T and targeted therapy technologies. The company’s pipeline is designed to expand on these early successes to more broadly impact other high-challenge cancers.

About the job

We are seeking a detail-oriented and highly experienced Quality Assurance Specialist II or III to join our team in ensuring compliance with regulatory standards and internal quality systems. This role plays a key part in maintaining product quality and integrity, driving continuous improvement, and supporting quality-related activities.

Responsibilities

• Lead executed manufacturing and testing document review and Final Product release.
• Lead and support investigations of deviations, non-conformances, and CAPAs.
• Author Quality related documents (including but not limited to SOPs, forms, plans, protocols and work instructions).
• Provide quality review of documents (including but not limited to SOPs, forms, plans, master batch records, protocols, reports and work instructions).
• Participate in audits and support regulatory inspections.
• Collaborate with cross-functional teams to resolve quality issues.
• Evaluate and approve change controls, risk assessments, and supplier qualifications.
• Provide QA support during product development, tech transfers, and validation activities.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 3-5 or 5–7 years of experience in pharmaceutical QA or a related GMP-regulated environment.
• Strong knowledge of cGMP, ICH guidelines, and applicable FDA regulations.
• Experience with document management systems and quality management software.
• Excellent attention to detail, problem-solving skills, and ability to manage multiple priorities.

Preferred Skills

• Experience in sterile/aseptic manufacturing, biologics, or Cell and Gene Therapies.
• Effective communication and interpersonal skills; team-oriented mindset.

Interested parties should apply to Olga Meystelman at [e-mail]. Please be sure to include that this is an application for the Position.

Find Us

BioHouston, Inc.
2450 Holcombe Blvd, TMCxi
Houston, TX, 77021