QA Associate - Systems

Union Agener•Augusta, GA

2d•Onsite

About The Position

The QA Associate - Systems role involves overseeing specific systems or functional areas, preparing and approving GMP documents, and implementing documentation control systems to ensure compliance with cGMP. This position will evaluate the quality impact of GMP incidents, participate in inspections, educate personnel on quality matters, and act as a backup for other QA colleagues. The role also includes tracking and reporting issues, executing and approving Change Controls, routing and releasing documentation, performing investigations, verifying action plans, conducting GMP area walk-throughs, completing CAPAs, and assisting with metric reporting to drive process improvement.

Requirements

Bachelor of Science Degree (4 year college) OR Associate's Degree with 2-3 years work experience in a GMP environment OR 10 years work experience in GMP regulated environment with pharmaceutical experience
Demonstrated relevant experience (Quality Assurance, Quality Control, Engineering, Operations, Technology) in a manufacturing facility regulated by the FDA and in compliance with cGMP.
Excellent verbal and written communication skills tailored to the appropriate audience.
Ability to work well at all levels within the organization, comfortable in a manufacturing environment.
Good interpersonal skills, planning, organization and prioritizing are essential.
Team building skills, along with the ability to facilitate action plans.
Must have knowledge of computer systems and software applications, including Microsoft Office applications.

Nice To Haves

Demonstrated Project Management Skills
Detailed and Results Oriented
Solid Computer Skills
Microsoft Office / SAP / SE Suite
Strong Interpersonal Skills
Ability to work effectively with respect for others in a team environment
Excellent communication and organization skills
Adapt readily to change and have the desire to experience new challenges and opportunities.

Responsibilities

Oversee specific systems or functional areas as assigned
Prepare, review, redline, and/or approve GMP documents supporting the site (Procedures, specifications, protocols, reports, change controls, deviations, etc.)
Implement and maintain systems for complete documentation and control of all required records, logs, and instructions necessary for compliance with cGMP.
Evaluate the quality impact for any GMP related incidents, triage initial corrective actions, and support the long-term resolutions.
Participate in self led and/or regulatory inspections.
Educate site personnel on quality matters.
Function as the back-up for other QA colleagues.
Track and report issues.
Evaluate and execute Change Control, documentation, and drawing requests.
Route-and-release documentation in the Quality System.
Perform training for new and existing team members, prepare training materials as necessary.
Perform Deviation Investigations.
Verify and approve Action plan for Change Control.
Perform walk-through of GMP areas.
Complete assigned CAPAs.
Assist in metric reporting to help drive process improvement for quality systems.
Provide hands-on support to all plant personnel in a 24/7 work environment.
Be on call to provide 'over the phone' or 'on site' support and direction.
Travel to all areas of the plant which may include walking, climbing, various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building.