Supervisor QA Process (3rd Shift)

Purpose and Scope

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.

Essential Duties & 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.
• Aid 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.

Knowledge, Skills & Abilities

• 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.

Core Values

• Center on People: Support the well-being of patients and treat employees and those served as valued partners.
• Proactive & Agile: Engage, adapt to change, respond swiftly and efficiently, and propel the organization towards extraordinary outcomes.
• Act Ethically: Conduct business ethically, comply, and be socially aware, cultivate diversity, equity, inclusion & sustainability in the workplace.
• Constantly Improve: Enhance products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality, embrace calculated risk-taking that drives better ways of working.
• Accountable: Be honest, transparent, and clear in alignment with core values, take accountability & ownership of work, actions, successes, and setbacks, strive to deliver best as we shape the future.

Education & Experience

• High school diploma or GED required.
• Bachelor’s degree in scientific discipline or related field preferred, not required.
• Six or more years of experience in the pharmaceutical or medical device industry in Quality Assurance (or equivalent combination of education and experience).

Working Conditions

Working conditions are normal for an office environment. Weekends and overtime may be required.

Compensation And Benefits

Pay: $83,000 - $95,000
Shift differential: 10%

Benefits summary

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.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.