Quality Assurance Specialist I

Quality Assurance Specialist I in Hopkinton, MA

Build your future at Curia, where our work has the power to save lives.

The Quality Assurance (QA) Specialist I is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations. This position’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 are maintained, and b) appropriate immediate corrective action is implemented and effectively documented in order 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.

Responsibilities

Maintain Quality databases and scanning of cGMP documents and records, Departures, media fill programs, and training files

Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented

Solicit feedback from various departments for operational improvement

Author, review, and / or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.

Assist in performing investigations

Perform and / or assist with internal audits, weekly walkthroughs, and / or external audits

Perform QA visual inspection activities associated with clinical and commercial drug product

With supervision, may respond or manage responses to clients regarding manufacturing and / or documentation issues

Develop and / or maintain Quality System metrics for management review

Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs

Qualifications

High School diploma or GED and a minimum of 4 years of related work experience, OR

AAS Degree in Chemistry or a related field and a minimum of 2 years of related work experience, OR

BA / BS Degree or higher in Chemistry or a related field.

Experience in a cGMP and FDA-regulated industry preferred.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Other Qualifications :

Must pass background check

Must pass drug screen

May be required to pass Occupational Health Screening

Pay Range :

$62,000 - $77,800 per 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.

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