Quality Assurance Supervisor

10 hours ago

Farmington, Michigan, United States Join Parachute Full time
Job OverviewParachute is seeking a highly skilled Quality Assurance Supervisor to join our team. As a Quality Assurance Supervisor, you will be responsible for managing the quality assurance operations of the Donor Center and supervising operations and quality control, while ensuring compliance with all applicable policies and regulations.Key Responsibilities
  • Lead and direct overall Donor Center quality compliance by ensuring the center is audit ready at all times and is compliant with industry regulations, government regulations, and with standard operating procedures.
  • Work with the Center Director to maintain product quality, integrity, and safety; donor suitability and safety; and employee safety.
  • Ensure that product meets all regulatory and customer requirements.
  • Maintain an independent level of quality inspection and control.
  • Participate in all formal regulatory audits with the Center Director and quality team and develop effective corrective action plans, as needed.
  • Oversee release of product and shipment of product to vendor and ensure that shipment meets all regulatory and customer guidelines.
  • Oversee product and biohazard waste shipments by doing the following: ensure shipments meet regulatory specifications and product release requirements, ensure accurate labeling and documentation, and authorize final shipment.
  • Work with the Center Director to determine donor suitability and manage donor deferrals, as needed.
  • Work jointly with the Center Director and trainers to develop employee knowledge that personnel performance is critical to the purity, safety, and integrity of the product.
  • Track industry trends and implement process improvement plans. Measure and determine effectiveness of said plans and adjust when needed.
  • Ensure compliance with all federal, local, state, and company regulations related to quality of product, employee, and donor safety.
  • Partner with the Center Director and training personnel to review the SOP and applicable forms to ensure that they are always current and ensure that employees are trained on any updates to SOP.
  • Hire, lead, develop, and manage Quality Assurance team.
Requirements
  • A bachelor's degree in Biological Science, Business Administration, Nursing, Finance, or a related field or equivalent experience.
  • At least 3 years of experience in a cGMP environment with plasma or whole blood experience or equivalent experience in a clinical or general business setting.
  • Proficiency with Microsoft Office Suite (Word, Excel)
  • Ability to travel by plane and/or car on occasion
  • Physical: Able to stoop, kneel, crouch, reach, pull, and lift a minimum of 50 lbs. Ability to sit or stand for extended periods of time.
  • Auditory and visual acuity.
  • Required to enter an environment (with suitable cold environment outerwear) with a temperature of -40°ree;C for short periods of time.
  • Ability to work day and evening hours, weekends, holidays and extended shifts as needed.
Benefits
  • Competitive compensation
  • Medical, Dental, and Vision insurance
  • Paid time off
  • Company paid holidays
  • Career growth opportunities

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