Center Quality Manager (Relocation Required)

Join Parachute; Austin (TX); Hybrid; USD 50,000 - 70,000; Full time

Benefits offered by this job

Competitive compensation with bonus potential

Medical, Dental, and Vision insurance

Paid time off

Company paid holidays

Career growth opportunities

Job summary

Join Parachute is looking for a Center Quality Manager who will oversee quality assurance processes in a Donor Center. This role requires relocation to one of our hiring centers, preferably in the Midwest. Key responsibilities include ensuring compliance with regulations, conducting final quality reviews of shipments, and guiding the management team on quality issues. A bachelor’s degree in Biological Sciences or related field and three years of experience in a cGMP environment are preferred. The position offers competitive compensation with bonus potential and comprehensive benefits.

Qualifications

• Bachelor’s degree in Biological Sciences or a related field, or equivalent education/experience.
• Three years experience in a cGMP environment preferred, or equivalent in clinical/general business.
• Proficiency in Microsoft Office Suite (Word, Excel).

Responsibilities

• Manage quality assurance processes in the Donor Center.
• Maintain compliance with SOP and regulatory guidelines.
• Perform final QA review and release of product shipments.
• Ensure the Donor Center is audit-ready.
• Assist in non-conformance and CAPA reporting.

Skills

Biological Sciences knowledge

Proficiency with Microsoft Office Suite

cGMP experience

Supervisory experience

Education

Bachelor’s degree in Biological Sciences or related field

Job description

Center Quality Manager (Relocation Required)

Department: Center Quality

Employment Type: Full Time

Location: Open Location

Compensation: Up to $70K ($50K - $55K base + up to 25% monthly bonus) + benefits

Please Note: This role will require relocation to one of the centers where we are actively hiring. Interest in relocating to one of our Midwest centers is preferred.

The Center Quality Manager is responsible for managing 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 all applicable policies and regulations.

Travel: 8 weeks of paid training with travel and accommodations provided.

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).

Work Environment & Physical Requirements

• 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