Center Quality Manager

Key Responsibilities

• Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP), and regulatory guidelines.
• Provides advice and consultation to management team members regarding daily quality assurance issues, including donor suitability and product quality. 
• Perform final QA review and release of all product shipments and associated documents to ensure shipment meets regulatory and customer specifications.
• Collaborate with the Center Director to complete all audit responses, ensuring that all audits are addressed and closed within the required time frame. 
• Ensure the Donor Center is audit-ready at all times.
• Perform staff observations. 
• Review equipment quality controls and cleanings
• Release equipment and supplies for use. 
• Ensure that unsuitable product is quarantined and destroyed.
• Review the maintenance requirements and updates of the Donor Center. 
• Review sample and product shipments. 
• Assist in non-conformance and CAPA reporting, documentation, and investigations as required. 
• Perform other duties as assigned.

Required Qualifications

• Bachelor’s degree in Biological Sciences or a related field, or an equivalent combination of education, training, and experience required. 
• Three (3) years of experience in a cGMP environment with plasma or whole blood experience preferred, or equivalent experience in a clinical or general business setting. 
• Supervisory experience preferred but not required.
• Proficiency with Microsoft Office Suite (Word, Excel).

• Ability to safely and successfully perform the principal job functions consistent with the ADA, FMLA, and other federal, state, and local standards. 
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA, and other federal, state, and local standards. 
• Ability to work day and evening hours, weekends, holidays, and extended shifts as needed. 
• Must be able to periodically lift and carry up to 50 lbs. 
• Must be able to sit or stand for extended periods of time. 
• Required to enter an environment (with suitable cold environment outerwear) with a temperature of -40°C for short periods of time. 
• Ability to work in a fast-paced environment with frequent interruptions. 
• Must possess auditory and visual acuity. 
• Frequent exposure to hazardous chemicals, extreme temperatures, and blood-borne pathogens. 
• Required to wear Personal Protective Equipment while performing specific tasks or in certain areas.  

Why Join Parachute?

• Competitive compensation with bonus potential 
• Medical, Dental, and Vision insurance
• Paid time off 
• Company paid holidays 
• Career growth opportunities