Quality Assurance Specialist

Forma Life Sciences•Irvine, CA

1d•Onsite

About The Position

Forma is a next-generation Contract Development and Manufacturing Organization (CDMO) based in Irvine, California. The company was recently formed through the acquisition of the Irvine operations from BioDuro and is operating as a newly established, independent entity. As a result, Forma’s standalone online presence is still being built. We are a lean, entrepreneurial organization of approximately 60 employees focused on drug product development and manufacturing for pharmaceutical and biotechnology clients. Unlike large, highly layered organizations, Forma operates with a hands-on, execution-driven model. Our teams work closely across functions to solve complex technical and operational challenges, move quickly, and deliver consistently high-quality results. Employees at Forma are expected to take on meaningful responsibility, collaborate directly with colleagues and clients, and contribute to building scalable systems and processes as the company grows. This is an environment well suited to individuals who value autonomy, technical excellence, and the opportunity to help shape a growing organization.

Requirements

Bachelor’s degree in science-related field is preferred.
Minimum 5 years of experience in Quality Assurance
Hands-on experience performing production line clearance, review/approval master and executed production batch records, review/approval of deviations and implementation of corrective and preventive actions.
Working knowledge of applicable CFR, ICH, and GMP regulations.
Ability to apply and enforce GMP compliance to all aspects of the position.
Detailed attention in job performance.
Excellent written and verbal communication.

Nice To Haves

Detailed attention in job performance
Good attitude, work ethic and natural leadership
Achievement of an advanced degree or certification
Excellent written and verbal communication

Responsibilities

Primary person responsible for review and approval of all batch records.
Work directly with clients to obtain approvals on batch records and client notifications.
Work with cross functional stake holders to ensure timely closure of batch associated deviations.
Support Materials Management in assignment of material codes, review/approval of raw material and packaging component specifications, and materials disposition.
Ensure suppliers of raw materials and services are approved according to the vendor management program.
Participate and assist with internal and external audits and regulatory inspections.
Work with the QA group to ensure inspection-readiness for all GMP operations, including compliance with CFRs, GMPs, company policies and procedures.
Provide hands-on support for data review/approval of analytical testing data summaries (such as in-process, release, stability, method validation, and cleaning validation/verification testing, environmental monitoring data) and ensure tasks are tracked and timelines are met.
Participate in laboratory investigations and ensure corrective and preventive actions are implemented.
Support quality exceptions including review/approval of deviations, CAPA, non-conformances, risk/impact assessment, and change management.
Comply with all safety regulations and Mechanical/Electrical/Fire Hazards encountered in Manufacturing/Laboratory Areas.
Other duties as deemed appropriate by the Supervisor or Head of Quality.