Quality Assurance Specialist

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.

Supervisory responsibilities:

This position does not have supervisory 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

• Bachelor's degree in Life Science or related field
• Minimum 0-3 years' experience in a cGMP and FDA-regulated industry

• Gowning qualification (may be required)

• 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

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms.

The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper personal protective equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment.

The noise level in the work environment is usually moderate. Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

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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