Quality Assurance Specialist III

Curia • Camarillo, CA

9d • $91,000 - $114,200

About The Position

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.

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
• And more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees