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Join Parachute

Plasma donation platform funds life-saving medicines

Center Quality Manager

Regulatory & Quality (Life Sciences)Updated on Nov 13
Full-timeTexas, USA$50k - $55kIn-person

About the Job

Requirements

  • A bachelor's degree in Biological Sciences or a related field, or an equivalent combination of education, training, and experience, is required.
  • Three years of experience in a current Good Manufacturing Practice (cGMP) environment with plasma or whole blood experience is preferred, or equivalent experience in a clinical or general business setting.
  • Proficiency with Microsoft Office Suite, including Word and Excel, is required.
  • Ability to perform the principal job functions safely and successfully in accordance with ADA, FMLA, and other applicable federal, state, and local standards.
  • Ability to maintain regular, punctual attendance consistent with ADA, FMLA, and other applicable federal, state, and local standards.
  • Ability to work day and evening hours, weekends, holidays, and extended shifts as needed.
  • Ability to periodically lift and carry up to 50 pounds and to sit or stand for extended periods.
  • Ability to enter an environment at -40°C for short periods while wearing suitable cold-environment outerwear.
  • Ability to work in a fast-paced environment with frequent interruptions.
  • Auditory and visual acuity.
  • Ability to work with frequent exposure to hazardous chemicals, extreme temperatures, and blood-borne pathogens.
  • Ability to wear personal protective equipment while performing specific tasks or in certain areas.

Responsibilities

  • Manage the implementation and maintenance of quality assurance processes in the Donor Center, collaborating with Corporate Quality Assurance and reporting to the Regional Performance Manager to ensure compliance with applicable policies and regulations.
  • Maintain compliance with standard operating procedures, current Good Manufacturing Practices (cGMP), and regulatory guidelines.
  • Advise and consult with management team members regarding daily quality assurance issues, including donor suitability and product quality.
  • Perform final quality assurance review and release of product shipments and associated documents to ensure shipments meet regulatory and customer specifications.
  • Collaborate with the Center Director to complete audit responses and ensure audits are addressed and closed within required time frames.
  • 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 unsuitable product is quarantined and destroyed.
  • Review the maintenance requirements and updates of the Donor Center.
  • Review sample and product shipments.
  • Assist with non-conformance and corrective and preventive action (CAPA) reporting, documentation, and investigations as required.
  • Perform other duties as assigned.

Desired Qualifications

  • Supervisory experience is preferred but not required.

About the Company

Join Parachute

Plasma donation platform funds life-saving medicines

Parachute runs a platform that connects people with plasma donation opportunities and compensates them for their time and contribution. Donors give plasma at partner donation centers, and the collected plasma is used to manufacture medicines that treat chronic illnesses such as immune disorders, liver disease, bleeding disorders, and cancer. The way it works is by recruiting donors, coordinating appointments, and providing payment for donations, helping facilities maintain a steady supply of plasma for therapies. Parachute differentiates itself by focusing on expanding the donor base and shortening the gap between donation and medicine production, aiming to reduce shortages and improve patient access. The company’s goal is to increase the availability of plasma-derived treatments by encouraging more people to donate and by ensuring a reliable flow of plasma to treatment manufacturers.

Company size
201-500
Company stage
Early VC
Total funding
$93.8M
Headquarters
United States
Founded
2020

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