H-1B Visa QA Analyst Jobs

INTRODUCTION

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!

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
• Conduct, review, and approve deviation and OOS investigations in accordance with GMP and site quality requirements
• 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

BASIC QUALIFICATIONS

• Bachelor’s Degree with a minimum of 5 years’ GMP and QA experience in an FDA-regulated pharmaceutical environment

Knowledge, skills and abilities

• 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

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

COMPENSATION

• Pay Range: $91,000-$114,200/year

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

LOCATION

Quality Assurance (QA) Specialist III in Camarillo, CA