Quality Assurance Analyst

University of California, Irvine•Irvine, CA

4d•Onsite

About The Position

The Quality Assurance (QA) Specialist will support a Quality Assurance Unit in the School of Medicine, cGMP Facility. The QA Specialist will report administratively to the Manager of Quality Assurance for GMP Operations. The QA Specialist will perform Quality Assurance activities to support GMP Manufacturing operations and process development activities, including but not limited to product label issuance/reconciliation, batch record issuance/review, Starting Material (i.e. Cell Banks) Receipt, Release, product disposition and Inventory Management, Logbook (i.e. Equipment Use, Facility Cleaning) Issuance and Management. In addition, the QA Specialist will support project teams in developing and implementing standards for inspection and accreditation, coordinating, preparing, and submitting Investigational New Drug (IND). Evaluate compliance of completed manufacturing records (batch records, COC/ COA, packaging, and any related data as applicable) from CMO as necessary to ensure accuracy and completeness. Collaborate with stakeholders to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process. Review development and qualification protocols and reports. Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls-related processes and regulatory requirements. Requires specialized knowledge for reports, external inspections, responding to inspection deficiencies and setting policy for quality assurance and compliance activities. Responsible for development, maintenance, and enforcement of the quality plan.

Requirements

Adherence to excellent customer service principles.
Organizational skills are sufficient to prioritize duties in an ever-changing environment.
Must possess technical vocabulary to meet facility needs.
Deep understanding of cGMP regulations and global guidelines from agencies like the FDA (Food and Drug Administration) and EMA (European Medicines Agency).
Ability to listen, collect information, and give instructions in an effort to support, clarify, or resolve problems.
Knowledge of personal computer, word processing, data management, and spreadsheet software.
Knowledge of standard precautions and biosafety.
Knowledge of Occupational Safety and Health Act (OSHA) and laboratory safety regulations.
Outstanding written and oral communication skills.
Ability to draft and review Standard Operating Procedures (SOPs), batch records, and technical reports that are audit-ready and clear.
Must be able to write clear technical reports in the scientific format.
Ensuring all records are Attributable, Legible, Contemporaneous, Original, and Accurate.
Maintains appropriate interdepartmental communication.
Ability to work well under pressure to meet commitments and to remain flexible with a variety of changing demands.
Ability to work as a member of a team and to assist colleagues as needed.
Ability to function and work in a diverse work environment.
Proficiency in using electronic systems for managing deviations, CAPAs, and change controls.
Knowledge of federal and state legislation and regulatory requirements pertaining to the cellular therapy production.
Bachelor's degree in Nursing or other relevant healthcare profession, or a combination of comparable clinical education and / or experience.
At least 1 year of experience in toxicology, chemistry, regulation of biologics
Experience in reviewing cGMP/GLP related documents (SOP’s, protocols, batch records, technical reports, etc.).
Must be able to provide proof of work authorization

Nice To Haves

2 years of experience in clinical laboratory setup

Responsibilities

Perform Quality Assurance activities to support GMP Manufacturing operations and process development activities.
Support product label issuance/reconciliation.
Support batch record issuance/review.
Support Starting Material (i.e. Cell Banks) Receipt, Release, product disposition and Inventory Management.
Support Logbook (i.e. Equipment Use, Facility Cleaning) Issuance and Management.
Support project teams in developing and implementing standards for inspection and accreditation.
Coordinate, prepare, and submit Investigational New Drug (IND).
Evaluate compliance of completed manufacturing records (batch records, COC/ COA, packaging, and any related data as applicable) from CMO as necessary to ensure accuracy and completeness.
Collaborate with stakeholders to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process.
Review development and qualification protocols and reports.
Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls-related processes and regulatory requirements.
Respond to inspection deficiencies and set policy for quality assurance and compliance activities.
Responsible for development, maintenance, and enforcement of the quality plan.
Conduct internal audits and prepare for regulatory inspections by managing documentation and hosting inspectors.
Catch minor discrepancies in batch records or production processes that could lead to product recalls.