Center Quality Assurance Supervisor - Rolla, MO jobs in United States
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Join Parachute · 3 months ago

Center Quality Assurance Supervisor - Rolla, MO

Join Parachute is a company that has reimagined the plasma donation experience through technology and compassionate design. The Center Quality Assurance Supervisor will manage quality assurance operations at the Donor Center, ensuring compliance with policies and regulations while supervising operations and quality control.

BiotechnologyHealth CareMedical
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Growth Opportunities

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. The Center Quality Director will liaise directly with auditors and ensure that all required quality tasks are completed within required time frames
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

Qualification

CGMP experienceQuality Assurance managementRegulatory complianceMicrosoft Office SuiteLeadership skillsCommunication skillsInterpersonal skillsOrganizational skills

Required

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°C for short periods of time
Ability to work day and evening hours, weekends, holidays and extended shifts as needed

Preferred

Excellent leadership skills. Prior experience managing a team of direct reports and the ability to effectively delegate, train, and provide constructive feedback is preferred

Benefits

Medical, Dental, and Vision insurance
Paid time off
Company paid holidays
Career growth opportunities

Company

Join Parachute

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Parachute is a new kind of plasma donation company that allows individuals to earn money while creating life-saving medicine.

Funding

Current Stage
Late Stage
Total Funding
$117.36M
2023-12-06Undisclosed· $57.55M
2023-06-13Undisclosed· $36.28M
2022-08-31Debt Financing· $5M

Leadership Team

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David Handal
CIO / VP Supply Chain
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Jennifer Duven, MD
CMO, Head of Medical and Regulatory Affairs
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Company data provided by crunchbase