Quality Manager

Grifols, S.A; Stonecrest (GA); On-site; USD 85,000 - 120,000; Full time

Job summary

Grifols is seeking a Center Quality Manager in North America (GA Stonecrest) to lead quality inspection, regulatory compliance, and donor safety programs. This role partners with Center Managers to ensure product quality and SOP adherence across all activities.

Key duties include leading audits, implementing CAPAs, maintaining QA documentation, and training staff to uphold cGMP and CLIA standards within the donor center.

Qualifications

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Working toward ASQ Certified Quality Auditor.
• Certification as a Designated Trainer for quality area is required.

Responsibilities

• Independent level of quality inspection and control; ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with applicable state, federal, and company regulations.
• Ensures SOPs are interpreted and staff follow them timely.
• Interprets and implements processes, regulations and SOPs for quality control and regulatory compliance.
• Oversees audits and corrective action processes, including documentation and responses.
• Promotes and improves quality systems in the donor center and tracks trends.
• Manages QA personnel functions and staff development.
• Oversees product and biohazard waste shipments and documentation.
• Performs root cause analysis for deviations and customer complaints.
• Documents and tracks incidents and reports compliance status.
• Ensures donor files accuracy and calibration of equipment.

Skills

Quality assurance

Regulatory compliance

Auditing

Staff training

Education

Bachelor of Science degree or equivalent

ASQ Certified Quality Auditor (or in progress)

Certified Trainer for quality area

Job description

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Center Quality Manager

Primary Responsibilities for role:

• Independent level of quality inspection and control -- ensures center compliance with quality standards and regulations.
• Collaborates with Center Managers to ensure product quality, donor suitability and donor safety.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Ensures that Standard Operating Procedures (SOPs) are properly interpreted, implemented in a timely fashion, and that the staff performs according to all SOPs.
• Interprets and implements processes, regulations and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Oversight of all aspects of internal and external audits including execution (if applicable). This includes documentation, review of and preparation of the response.
• Also including implementation of corrective and preventative action, assessment of corrective and preventative actions and follow-up as required.
• Continuously assesses, promotes, and improves the effectiveness of the quality systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, direct employee observation and review of center documents.
• Responsible for the personnel functions of the Quality Assoc(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all
• Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment.
• Performs a review of the documentation of unsuitable test results and the disposition of the associated results.
• Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
• Documents and tracks/trends center quality incidents and follows-up on incidents/errors as required; reports critical incidents and problematic trends to Center Manager.
• Reports compliance status to necessary parties.
• Ensures accuracy of donor files.
• Directs the maintenance and calibration of equipment and documentation of procedures.
• Ensures that Clinical Lab Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.
• Monitors training documents to ensure compliance with all applicable policies and procedures.
• Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.
• Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.
• QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center’s manual.
• Partners with the Center Manager to determine donor suitability activities and manages donor deferrals as appropriate.
• Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues.
• Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.

Job Requirments:

Bachelor of Science degree or equivalent. Certified and proficient in quality and compliance. Works toward certification from American Society for Quality to be a Certified Quality Auditor. Certification as a Designated Trainer for quality area is required.

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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.

Location: NORTH AMERICA : USA : GA-Stonecrest : [[cust_building]]