Sr. Quality Specialist

Company: Texcell
Location: Frederick
Posted on: February 22, 2026

Job Description:

Job Description Job Description Salary: from $90,000 Our Mission At Texcell, our mission is to safeguard the medicines of today and tomorrow by providing essential services to the global biopharmaceutical industry. As experts in pharmaceutical sciences, our clients develop life-changing therapies for patients worldwide. As specialists in viral safety and bioassays, Texcell ensures the safety of these therapies throughout development. Together, we make medicines safe. Our History Founded in 1987 at the Pasteur Institute in Paris, Texcells journey began with a laboratory team dedicated to addressing the HIV crisis. It was here that some of the earliest viral validation studies were conducted. Over the decades, weve continued to advance the science of viral safety, ensuring that patients can trust every dosetoday and in the future. Position Summary The Sr. Quality Specialist provides technical quality oversight for laboratory and manufacturing/support activities under GMP and GLP. This role is responsible for ensuring phase-appropriate compliance of viral safety assays, viral clearance studies, and cell bank production/testing, as well as maintaining and continuously improving key quality systems. Key Responsibilities Provide QA review and approval of study plans, protocols, and reports for viral clearance, viral safety, characterization studies, batch records, cell banking documentation (MCB/WCB), and test records. Perform detailed review of raw data, calculations, and data traceability for GLP/GMP activities. Ensure systems comply with 21 CFR Parts 210/211, 58, 11, relevant ICH and GLP/GMP expectations. Oversee method qualification/validation (e.g., per ICH Q2 concepts) for viral assays and cell bank testing, equipment qualification (IQ/OQ/PQ) and maintenance for controlled environments and critical instruments. Examine validation and qualification documentation to confirm scientific integrity and compliance standards are met Deliver GMP/GLP QA oversight for cell bank manufacturing, testing, and release, including sterility, mycoplasma, adventitious agents, identity, purity, and stability assessments. Ensure proper chain of custody, sample handling, and storage conditions throughout all testing activities. Plan and conduct internal audits of laboratories, manufacturing, and quality systems. Lead and/or support client audits and regulatory inspections, including preparation, on-site activities, and management of responses. Promote and enforce ALCOA data integrity requirements across all paper and electronic platforms (LIMS, QMS/eQMS, ELN, Part 11compliant systems). Design and deliver targeted GMP, GLP, and quality system training for laboratory, operations, and support teams. Ensure that investigation records (Deviations, Complaints, Lab Investigations, OOS) are promptly initiated, thoroughly investigated, and effectively resolved. Other duties as assigned. Education & Experience: Bachelors degree in Biology, Microbiology, Biotechnology or related field and 5 years of quality experience in GMP and GLP environments (i.e., CRO, CDMO, biopharma). Hands-on experience in regulated laboratory operations with GMP-quality systems supporting manufacturing, release testing, or cell banking Familiarity with Biologics (mAbs, recombinant proteins) and/or cell and gene therapy products, common analytical methods for viral detection, clearance, and cell line characterization. Experience with LIMS, eQMS, ELN, and other GxP-compliant electronic systems. Skills & Competencies: High technical rigor, strong attention to detail, and scientific literacy. Clear, concise written and verbal communication. Ability to operate effectively in a small, fast-paced, cross-functional environment. Strong problem-solving skills with a pragmatic, risk-based mindset. Working Conditions: Regular on-site presence is required to provide hands-on QA oversight of GxP activities, including lab walkthroughs, data reviews, and support during client/regulatory visits. Core business hours are MondayFriday, 8:00am-4:30pm. Must be able to work mornings, evenings and/or weekends as required. Work involves regular interaction with biohazardous materials and GxP-controlled areas; adherence to safety procedures and use of appropriate PPE is mandatory. Extended periods of screen/computer work, documentation review, and participation in meetings and ability to sit or stand for extended periods while performing documentation review or participating in audits. Position requires visual acuity to review paper and electronic records, raw data, and audit trails with a high level of accuracy.

Keywords: Texcell, Arlington , Sr. Quality Specialist, Science, Research & Development , Frederick, Virginia