Quality Assurance Specialist III

Curia • Camarillo, CA

21h • $91,000 - $114,200 • Onsite

About The Position

Quality Assurance (QA) Specialist III in Camarillo, CA
Build your future at Curia, where our work has the power to save lives.
The Quality Assurance Specialist III is responsible for maintaining Quality Systems and work cross functionally with Manufacturing, Project Management, etc. The QA Specialist’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMPs and internal procedures/policies is maintained, b) appropriate immediate corrective action is implemented and effectively documented to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.
Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
We proudly offer
• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Requirements

• Bachelor’s Degree with a minimum of 5 years’ GMP and QA experience in an FDA-regulated pharmaceutical environment
• Excellent written and verbal presentation and communication skills
• Strong problem-solving skills, with the ability to resolve conflict
• Ability to effectively present information to management and/or peers
• Comfortable working independently in combination with individuals in other departments across the organization
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Responsibilities

• Work cross-functionally with Manufacturing, Process Engineering, Technical Operations, Inspection, and Project Management to support Right First-Time execution of operations at the site
• Review Executed batch records, quality control testing data, and environmental monitoring data for compliance with internal SOPs and specifications, assess lot associated deviations, CAPA, and change controls for cumulative impact, and conduct Batch disposition for clinical, developmental, and commercial products
• Review and approve procedural changes
• Attend client meetings and manage responses to clients regarding manufacturing and/or documentation issues
• Review and approve protocols and executed validation documentation
• Work in coordination with the QA Management to ensure client timelines are on schedule and attainable
• Author or revise SOPs
• Assist or review deviations and OOS investigations
• Assist in developing and delivering training
• Develop and/or present metrics for Management Review
• Assist in the compilation of documentation, systems, and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for regulatory and client audits
• Participate in regulatory and client audits
• Represent CURIA Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented
• Other duties may be assigned

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level