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Quality Assurance Management Specialist
2 months ago
Our client, a dynamic organization with multiple manufacturing facilities, is seeking a Quality Management System (QMS) Specialist to support their expansion into pharmaceutical production. This role offers a competitive salary along with relocation assistance and a comprehensive benefits package.
Position Details:Job Title: Quality Management System (QMS) Specialist
Location: Not specified
Compensation: Annual salary ranging from $80,000 to $100,000
Relocation: Assistance available for reasonable expenses
Benefits: Comprehensive medical and dental insurance, 401K, and 13 days of paid time off.
Company Overview: The organization is a privately owned entity with manufacturing sites across the country, employing approximately 300 individuals.
Team Information: Join a dedicated group within the medical device and pharmaceutical contract manufacturing sector, currently comprising over 120 employees with plans for further growth. The Quality department includes around 25 professionals specializing in Quality Control, Quality Assurance, and Compliance. The selected candidate will oversee the Technical Administration of the Quality Management System – MasterControl and will report directly to the Senior Director – Head of Quality.
Role Responsibilities:
- Manage the implementation of the QMS software - MasterControl to streamline and integrate quality-related functions including Training, Document Control, SOP Management, CAPA, Deviation, Change Control, and Audit management.
- Act as the Administrator of the QMS system, providing support to users across Quality, Production, and Regulatory departments to ensure effective utilization.
- Serve as a Subject Matter Expert (SME) for MasterControl.
- Oversee the management of SOPs, ensuring proper user verification and compliance with necessary procedures. Monitor Batch Control to confirm adherence to manufacturing processes, and ensure Training is conducted effectively for all employees.
Qualifications:
- Education: Bachelor’s Degree or equivalent experience.
- Experience: Minimum of 3 years in QMS within the Medical Device or Pharmaceutical Industry.
- Ability to manage multiple priorities and adapt to changing demands.
- Strong multitasking skills with a sense of urgency to meet deadlines.
- Leadership qualities to initiate and fully implement QMS processes.
- Meticulous attention to detail with a track record of dependable and accurate work.
Preferred Qualifications:
- Familiarity with Sterile Aseptic Filling Operations.
- Experience in a startup or small company environment, demonstrating a hands-on approach.
- Background in Contract Manufacturing with a focus on client relations.
- Experience with QMS – MasterControl as utilized by the organization.
Keywords: BioPharma, Pharmaceutical, Quality Assurance, FDA, QMS, MasterControl, Sterile, CDMO, Manufacturing.
