Supervisor - Plasma Quality Assurance

1h1 hour ago

Grifols

Clayton, US · Full-time · $85,000 – $110,000

About this role

Grifols is a global healthcare leader in plasma-derived medicines and transfusion medicine, operating in over 110 countries. As the Supervisor of Plasma Quality Assurance on 2nd shift, you will coordinate and supervise the inspection and release of plasma lots for sale or further manufacture, ensuring compliance with approved procedures and regulatory standards.

In this role, you will oversee the daily activities of the quality assurance staff, including the receipt, storage, clearing, and processing of Lookback Alerts, as well as the quarantine of unsuitable units and release of Source Plasma. You will verify critical systems and documentation associated with plasma destruction and ensure all shipment contents meet standard operating procedures, regulatory, and customer requirements prior to release.

You will investigate and document deviations from routine compliance reviews, internal and external audits, and customer complaints. The position requires flexibility for overtime and weekend shifts (every 3rd weekend), and the shift may change with business needs. You will interface with multiple levels of management and various support and service groups both internally and externally.

This position offers the opportunity to lead a dedicated QA team in a highly regulated, mission-critical environment. You will participate in writing and revising policies and procedures, monitor plasma operations for cGMP compliance, and contribute to the company's financial objectives by monitoring department costs.

Requirements

Bachelor’s degree in life sciences or related field ideal.
Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals.
Project or technical leadership experience required.
Supervisory or management experience preferred.
Strong analytical, organizational, and interpersonal skills with extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines.
Excellent written, verbal, and leadership skills; must be able to make sound decisions that may affect the quality, purity, or efficacy of a drug product.
Ability to anticipate and identify problems, analyze situations, consider alternatives, monitor, and evaluate results.

Responsibilities

Supervise the daily activities of the quality assurance staff, including hiring, performance management, disciplinary action, and professional development.
Coordinate and supervise the inspection and release of plasma lots for sale or further manufacture.
Verify critical systems and documentation associated with the destruction of plasma.
Ensure compliance to approved procedures and release plasma from the Plasma Logistic Center (PLC) after verifying shipment contents meet SOP, regulatory, and customer requirements.
Review and verify temperature documentation to ensure conformance to appropriate temperature specifications.
Investigate and document deviations noted from routine compliance reviews, internal and external audits, and customer complaints.
Participate in the writing and revision of policies and procedures related to Source Plasma at the facility.
Monitor Plasma Operations to maintain compliance with all applicable regulations, cGMPs, and CFRs, and participate in internal audits.

Benefits

Opportunity to work with a global healthcare leader in plasma-derived medicines and transfusion medicine.
2nd shift schedule: Monday – Thursday, 1:30pm – 12:00am.
Flexibility for overtime and weekend shifts (every 3rd weekend).
Role based in Clayton, NC, at a Plasma Logistic Center.