Senior Quality Assurance Specialist I PC 604

Miltenyi Biotec•San Jose, CA

27d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in life science
5+ years of direct QA experience related to GMP Manufacturing in the biotechnology or pharmaceutical industry.
Experience working with Quality Systems, writing deviations, CAPAs, Change Controls.
Experience in supporting/assisting the internal and external audits, inspections.
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.
Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Nice To Haves

Experience in cell-based therapeutics or biopharmaceuticals preferred.

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.