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QMS Specialist in Pharmaceutical Manufacturing
2 months ago
Our client, a dynamic organization with several manufacturing facilities across the United States, 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: Lawrence, KS
Compensation: Annual salary ranging from $80,000 to $100,000
Relocation: Yes, assistance for reasonable expenses is provided
Benefits: Comprehensive medical and dental insurance, 401K, and 13 days of paid time off, among others.
Company Overview: The organization is privately owned and operates manufacturing sites in California and Kansas, employing approximately 300 individuals.
Team Structure: Join a growing team within the medical device and pharmaceutical contract manufacturing sector, currently consisting of over 120 employees with plans for further growth. The Quality department comprises 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.
Key Responsibilities:
- Administer the QMS software - MasterControl to streamline and integrate quality-related functions including Training, Document Control, SOP Management, CAPA, Deviation, Change Control, and Audit management.
- Provide support to all users across Quality, Production, and Regulatory departments to ensure effective utilization of the QMS.
- Act as a Subject Matter Expert (SME) for MasterControl.
- Oversee the management of SOPs to ensure compliance with processes, including verifying user sign-offs and batch control to confirm adherence to manufacturing protocols.
- Facilitate training programs to ensure all employees receive proper training and track their progress.
Qualifications:
- Bachelor's Degree in a related field or equivalent experience.
- Minimum of 3 years experience in Quality Management Systems within the Medical Device or Pharmaceutical industry.
- Strong ability to manage multiple priorities and work under pressure.
- Leadership skills to effectively implement the QMS.
- Exceptional attention to detail and commitment to producing accurate work.
Preferred Qualifications:
- Familiarity with Sterile Aseptic Filling Operations.
- Experience in a startup or small company environment with 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, Pharma, Quality, FDA, QMS, MasterControl, Sterile, CDMO, Manufacturing, Plant.