Quality Event Management Specialist
|Monroe, North Carolina - United States
$45,000.00 - $65,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Quality Event Management Specialist to join our growing team. The Quality Event Management Specialist is responsible for initiating, reviewing and approving site Change Controls, CAPAs Deviations and Incidents, at a minimum within the Quality Management System (QMS). This role will actively support Change Control, CAPA, Deviation and Incident Review Board meetings with cross functional teams. Additionally, this role is also responsible for supporting the site Quality Management Review meetings and other duties at the discretion of the QEM Manager.
Responsibilities include but are not limited to:
- Implements process flows that ensure on-time closure of records and projects.
- Reviews and process Change Controls, CAPAs, Deviations and Incidents in QMS in a timely manner.
- Performs trending and monitoring of QMS to drive continuous improvement for the site.
- Maintains current knowledge of regulatory and industry standards, trends and advancements.
- Supports regulatory inspections.
- Develops Standard Operating Procedures (SOPs).
- Trains and supports colleagues in the electronic QMS.
- Mentors and supports other departments to meet GMP compliance.
- Ensures Quality Management Reviews are performed per SOP.
- Ensures continuous improvement within the QMS.
- Minimum Bachelor’s degree in scientific discipline or closely related technical field of study.
- Minimum of four (4) years of experience in Quality or Design Assurance in the Pharmaceutical, Biotech, or Medical Device industry.
- High level understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
Knowledge & Skills:
- Technical expert with excellent written and oral communication, as well as interpersonal relationship skills.
- Strong organizational, analytical, troubleshooting and problem-solving skills; ability to analyze details and perform structured decision-making on a daily basis.
- Proactive, results oriented, and a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Ability to read, write, and speak English.
- Excellent computer skills with expert knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
- Knowledge of SAP and MasterControl (preferred) or other electronic document system (e.g., TrackWise, LIMS, etc.) is required.
- Strong knowledge of the change management quality system with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team. Ability to analyze details and perform structured decision-making on a daily basis.
- Ability to handle an ever changing, fast-paced critical work environment
- Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Other Requirements(licenses, certifications, specialized training):
- Lean Six Sigma experience is a plus.
- Certified Quality Auditor (CQA) or Engineer (CQE) is a plus.
University - Bachelor's Degree/3-4 Year Degree