Quality Assurance Specialist III

Position overview

The Quality Assurance (QA) Specialist III is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action. The QA Specialist III primarily works in the cGMP areas to manage adherence to the quality system and initiate the 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.

Essential job duties

1. Assist in developing and conducting training of personnel in full accordance with cGMPs and Curia’s quality system to ensure real-time compliance
2. Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
3. Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
4. Assist in Curia documentation compilation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
5. Author, revise and/or review and approve Quality Management System documents, including, but not limited to, SOPs, CAPAs, Deviations, Un-executed/Executed quality records, Change Controls, test methods, protocols (stability, validation, etc.), executed validation documentation, certificates of analysis and/or equipment qualification documentation
6. Assist in internal and external audit programs and prepare reports as required. This may include planning audits, conducting audits and writing audit reports
7. Participate in and/or perform regulatory, client, and external supplier qualification audits as well as internal audits and weekly walkthroughs
8. Assist in or lead investigations
9. With supervision, may respond or manage responses to clients regarding manufacturing, testing, and/or documentation issues
10. Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
11. Develop, support and/or maintain Quality System metrics for management review
12. Support QA specialists to ensure client timelines are on schedule and attainable. This includes communicating directly with internal project teams and customer contacts
13. Assist in resolving quality problems/concerns with various personnel
14. Provide on the floor support and oversight to operations, including coordinating and perform day to day activities as needed
15. Actively participate in quality improvement initiatives, including development and implementation

Education, experience, certification and licensures 

Required

• Bachelor’s degree in Life Sciences or related field; alternate fields of study may be considered in combination with significant industry experience
• Minimum 6-8 years’ QA experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry

Preferred

• Experience working with third-party contract manufacturing in the pharmaceutical industry
• Gowning qualification (may be required)

Knowledge, skills and abilities

1. Excellent written and verbal presentation and communication skills
2. Strong facilitation skills
3. Strong problem-solving skills, with the ability to resolve conflict
4. Ability to effectively present information to management and/or peers
5. Comfortable working independently and proactively in combination with individuals in other departments across the organiza