Grifols - Los Angeles, CA

posted 9 days ago

Full-time - Senior
Los Angeles, CA
Chemical Manufacturing

About the position

The Quality Operations Manager is responsible for overseeing the inspection and release of intermediate products and finished goods at Grifols Biologicals. This role involves managing quality aspects of visual inspection and packaging operations for final products, ensuring compliance with GMP regulations, and leading a team to maintain high-quality standards in the production process.

Responsibilities

  • Manage the inspection and release of intermediates and finished products.
  • Oversee the visual inspection, labeling, and packaging operations.
  • Lead, develop, and mentor staff at various levels.
  • Evaluate and manage employee performance and conduct performance reviews.
  • Monitor compliance with current GMP regulations and applicable standards.
  • Review and establish resource requirements for materials, equipment, and manpower.
  • Direct daily activities of the department and manage inventory transactions in the MRP system.
  • Ensure accurate documentation and timely review of batch records from visual inspection and packaging operations.
  • Report trends of rejects and perform product recall simulations.
  • Investigate and initiate corrective actions for quality-related issues.
  • Participate in regulatory and internal inspections/audits.

Requirements

  • Bachelor's degree in Biology, Chemistry, or a related Science/Engineering field.
  • Seven years of related experience in a cGMP Quality department in an FDA regulated industry, with at least three years in a leadership role.
  • Demonstrated leadership skills with the ability to guide, train, coach, and develop subordinates.
  • Strong analytical, documentation, organizational, and interpersonal skills.
  • Extensive knowledge of cGMPs as specified in US and EU regulations.
  • Excellent written and verbal communication skills.
  • Proficient in MS Office applications.

Nice-to-haves

  • Prior experience with visual inspection techniques for liquid products.
  • Ability to perform multiple project tasks.

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Tuition reimbursement
  • Paid time off
  • 401(k) with 5% match
  • 401(k) matching
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