Quality Assurance Specialist I

Curia•Springfield, MO

34d

About The Position

Position overview The Quality Assurance (QA) Specialist 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. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 Paid training, vacation and holidays Career advancement opportunities Education reimbursement 401k program And more! Supervisory responsibilities This position does not have supervisory responsibilities.

Requirements

Bachelor’s degree in Life Science or related field
Minimum 0-3 years’ experience in a cGMP and FDA-regulated industry
Excellent verbal and written communication skills
Focused self-starter with attention to detail
Team-oriented, but able to work independently and proactively
Ability to multi-task
Strong problem solving and organizational skills
Strong critical thinking skills, including familiarity with root-cause analysis

Nice To Haves

Gowning qualification (may be required)

Responsibilities

Maintain Quality databases including Archival 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