Supervisor QA Process (3rd Shift)

Tolmar•Fort Collins, CO

9h•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.