Center Quality Manager (220225-052) Job in Rexburg 83440, Idaho US

Biomat USA, Inc., a part of the global Grifols family of companies, specializes in the collection of plasma for use in life-saving therapies. Biomat USA, Inc., along with PlasmaCare, Inc., have a network of over 80 plasmapheresis donor centers throughout the United States. These state-of-the-art facilities collect plasma from donors and operate according to the highest standards of quality.

Primary Responsibilities for role:

Independent level of quality inspection 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 fasion 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 Associate(s); including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks.

Oversees product and biohazard waste shipments. Ensures shipments meet regulatory specifications and product release requirments; 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.

Works in collaboration with the Center Manager to develop the staff's knowledge of their job function and how their performance relates to the end product and patient.

Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they related to the safety of the donor and the quality of the product.

Other Responsibilities for role:

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.

Ensures that all supplies and materials ordered meet quality requirements prior to use and are stored in appropriate temperature/facility conditions at all times. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance.

Directs the maintenance and calibration of equipment and documentation of procedures.

Monitors training documents to ensure compliance with all applicable policies and procedures.

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.

Performs a review of lookback information.

Ensures that job and Current Good Manufacturing Practice (cGMP) training is completed, documented, and on file.

Reviews and approves of deferred donor reinstatement activities.

QM directs routine verification of the SOP and forms to ensure that they are up to date in the Donor Center’s manual.

Ensures that quality control (QC) checks are performed as required and are in acceptable ranges for test reagents.

Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented.

Tracks/Trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. Makes adjustments where required.

Builds rapport with donors to ensure overall customer satisfaction with the Center to support long-term donation.

Performs a review of medical incident reports and the applicable related documentation.

Performs other duties as required.

Required Skills

Command of interpersonal communication, organizational and problem-solving abilities. Ability to understand and assess FDA regulations. Strong integrity and commitment to quality and compliance.

Full command of mathematics. Legible handwriting. High level of proficiency with computers. Proficient in root cause analysis and corrective/preventative actions. Ability to balance multiple competing priorities. Strong time management abilities. Proven ability to maintain a high level of quality and compliance and to become a valuable member of the center leadership team. Ability to work with minimal supervision. Ability to travel when needed for meetings, events, and occasional support of other centers.

Experience Required

Typically requires 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood.

Please apply directly at
http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjobjobid=220225company_id=16052jobboardid=24