Your Role:
This position provides quality assurance oversight for cGMP manufacturing of advanced cell and gene therapy products. Ensures strict compliance with FDA, EMA, ISO and other applicable regulations through real-time shop-floor support, batch record review, and disposition of raw materials and final drug products. This position also supports the implementation of the quality systems in compliance with cGMPs and other company policies.
Essential Duties and Responsibilities:
- Perform review of batch records for intermediate or final product, cell banks including in-process testing, QC release testing data packages, labeling, packaging, and all supporting documentation
- Inspect, review, and disposition raw materials, reagents and components
- Facilitate investigations relating to manufactured products and raw materials
- Provide QA oversight and QA on the floor support during GMP manufacturing operations
- Conduct line clearances, in-process inspections, support final product packaging operations, etc.
- Assist cross-functional teams with the initiation, investigation, and approval of Change Controls, Deviations, and CAPAs, providing critical QA input throughout.
- Create, review and revise standard operating procedures, study protocols, reports, and other GxP documents as needed.
- Coordinate the release of final cell-based therapeutic products for clinical and commercial applications.
- Participate in audit of internal departments, external clients, suppliers, and service providers and completion of audit reports as needed.
- Review and approve validation and qualification packages including installation, operation, and performance qualifications (IQ, OQ, PQ) protocols and reports as necessary.
- Train and provide QA guidance to internal functional groups on Quality Systems.
- Provide environmental monitoring support as needed.
- Participate in internal and client facing meetings as needed.
- 8:00am to 5:00pm with irregular hours/weekends/nights.
- Other duties as assigned
Requirements:
- Bachelor's degree in life science; 5+ years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry.
- Experience in cell-based therapeutics or biopharmaceuticals preferred.
- Experience working with Quality Systems, writing deviations, CAPAs, Change Controls.
- Experience in supporting/assisting the internal and external audits, inspections.
Knowledge / Skills / Abilities:
- Strong knowledge of cGMPs and FDA, EMA, ICH, and ISO regulatory requirements.
- Knowledge of Quality Systems, including Deviations, CAPAs, Change Controls, document control, and training processes.
- Knowledge of batch record review, Good Documentation Practices (GDP), and product release activities.
- Knowledge of validation and qualification activities, including IQ/OQ/PQ.
- Strong investigation, problem-solving, and risk assessment skills.
- Strong technical writing, document review, and communication skills.
- Ability to provide QA oversight in a GMP manufacturing environment.
- Ability to support audits, inspections, and regulatory readiness activities.
- Ability to work effectively with cross-functional teams and provide QA guidance.
- Strong attention to detail and ability to make compliant quality decisions.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
Work Environment:
This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.
The anticipated base salary range has been established at $120,988 - $142,405/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.
