Supervisor QA Process (3rd Shift)

Tolmar Careers • Fort Collins, CO

19h • Onsite

About The Position

Provides direct supervision of a team of QA associates. Responsible for overseeing the daily operations of the Process Quality team. Provides guidance to ensure compliance with procedures and regulations for QA manufacturing support.

Requirements

• Knowledge in cGMP and ISO 13485.
• Excellent working knowledge of current Good Manufacturing Practices for Finished Pharmaceuticals and/or Medical Devices.
• Skill in effective oral and written communication.
• Skill in Procedure writing.
• Skill in effective computer operation.
• Ability to coordinate activities to assure customer needs are met.
• Ability to work effectively within multi-disciplinary project teams.
• Ability to gain understanding and acceptance from others in sensitive situations.
• Ability to be independent, organized, and to lead others to meet deadlines.
• High school diploma or GED required.
• Six or more years of experience in the pharmaceutical or medical device industry in Quality Assurance (or equivalent combination of education and experience).

Nice To Haves

• Bachelor’s degree in scientific discipline or related field preferred, not required.

Responsibilities

• Manage the development, implementation and maintenance of Quality Assurance systems and activities.
• Review and approve documents used in Good Manufacturing Practices through the document management system.
• Provide quality oversight related to manufacturing processes.
• Perform investigations associated with the Quality Operations department.
• Review and approve minor deviations.
• Develop materials for and administer Competency Based Training (CBT).
• Review and approve certificates of analysis for raw materials.
• Identify training needs for direct reports and ensure compliance with training requirements.
• Prepare and administer employee appraisal and performance documentation.
• Assist Manufacturing and QA departments as needed in process improvement projects.
• Provide KPI data for “Right the First Time” for quality operations department.
• Supervise the following activities of QA employees to ensure schedules and performance requirements are met: Time off request management, Material and labeling sampling and inspection, Finished product sampling and inspection, Retains of products, Manufacturing support, Cleaning and monitoring of inspection areas.
• Perform various other duties as assigned.

Benefits

• Pay: $83,000 - $95,000
• Shift differential: 10%
• Benefits summary: https://www.tolmar.com/careers/employee-benefits
• Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package.
• The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 251-500 employees