QA Manager​/Sr. Manager; QA Final Container Release

Shift:

First shift

Responsible for managing all aspects (batch release, documentation, compliance, training, staffing budgetary needs, etc.) of the Quality Assurance Final Container Release group.

• Manages all aspects of the QA FC Release group (batch release, documentation, compliance, training, staffing budgetary needs, etc.).
• Consults with manufacturing, logistics, regulatory affairs, and Grifols sister sites on batch release matters.
• Uses expertise and sound judgment to make independent decisions regarding product batch release and systems.
• Plans and analyzes workflow, delegates and prioritizes to ensure that batches are released in a timely manner to meet company goals and market demand.
• Investigates and initiates corrective actions for batch release related issues.
• Provides effective leadership to employees in the Quality Assurance FC Release group.
• Reviews and revises Standard Operating Procedures and generates reports.
• Participates in regulatory inspections/customer audits including providing written responses as applicable for FC Release related topics.
• Applies quality risk‑based processes to seek continuous improvement of release systems and processes.
• Practices high level of facilitation skills to reach consensus and works toward solutions.
• Collaborates and efficiently communicates with internal and external customers.
• Demonstrates high levels of value and integrity.
• Demonstrated skills in managing projects to bring in on budget, on schedule, and technically correct (Sr. Manager level).
• Acts as the site Recall/Withdrawal Coordinator.
• Follows cGMP and department safety practices.

In addition to the duties described above the QA Manager must have excellent communication skills (written and verbal) and extensive working knowledge of applicable regulations (i.e. U.S. Food and Drug Administration, Eudralex, Health Canada) and other applicable regulatory agency requirements/guidelines. They must be able to perform methodical, risk‑based analysis of situations and propose improvements. They must have good organizational skills and a demonstrated sense of urgency and ability to follow up, in a timely manner, on items until completion.

NORTH AMERICA : USA : NC-Clayton:

USNC
0002 - Clayton

Learn more about Grifols:

539637

Regular Full‑Time

TECHNICAL

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.