Experienced Center Quality Manager with multiple years in Quality Assurance experience and Operations. Dedicated to detail-oriented production inspections and collaborating with various departments. Successful at internal audits and establishing effective quality procedures, standards and specifications. Experience in maintaining smooth and efficient operations through effective team leadership and management. Possesses excellent budget management, human resources and analytical problem-solving abilities.
Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation
Kept records of quality reports and statistical reviews.
Created, edited and updated project manuals and technical documentation used by entire QA team.
Delivered reports on quality control metrics to internal departments for analysis as well as to outside vendors and contractors for consideration in new contracts.
Trained and developed employees in effort to contribute to overall professional growth.
Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
Reviewed employment applications, candidate backgrounds, skills, compensation needs and other qualifications.
Provided hiring status updates to HR and managers for comprehensive oversight.
Coordinated monthly budgets, managed profit and loss and consistently met desired margin targets.
Evaluated building condition, workflow and service quality to keep operations in compliance with requirements.
Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
Appraised inventory levels on frequent basis, ordering new merchandise to keep quantities well-stocked.
Strengthened and aligned daily operations with patient needs based on collected feedback and continuous improvement plans.
Oversaw ordering, purchasing and maintenance of clinical equipment.
Managed clinical budgets, billing systems and insurance negotiations.
Developed relationships with healthcare providers to sustain strong referral pipeline.
Complied with OSHA and HIPAA regulations.
Created and maintained electronic record management (EMR) systems to store data and develop reports.
Ensure SOP and revisions comply and are implemented correctly, including system process assessments to make the systems more efficient and effective
Reviewed and submitted accurate bi-weekly payroll to satisfy human resources obligations and maintain high employee satisfaction.
Evaluated building condition, workflow and service quality to keep operations in compliance with requirements.
Coordinated monthly budgets, managed profit and loss and consistently met desired margin targets.
Recruited and hired individuals demonstrating passion, dedication and added value to team.
Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
Trained and developed employees in effort to contribute to overall professional growth.
Delivered reports on quality control metrics to internal departments for analysis as well as to outside vendors and contractors for consideration in new contracts.
Managed completion of planned audits, reviewed records and procedures for accuracy to accomplish objectives and appraised policies and plans under audit review.
Recruited and hired qualified candidates to fill open positions.
Kept records of quality reports and statistical reviews.
Ensure center is “inspection ready” at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation.
Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.
Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management.
Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination.
Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation.
Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures.
Perform final QA review for all shipment and associated documents to ensure shipment meets costumer specifications.
Coordinate and monitor all training, such as new hire, annual and any training to meet center regulatory requirements.
Collaborates with center management to identify, coordinate, and deliver retraining for the purpose of correcting or improving operational or quality issues.
Ensure center records are reviewed with thoroughness, accuracy, and timeliness of required information. Initiate Investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action and effectiveness of action.
Promote safety, health, and environment policy & procedure. Ensure safety training and safety practices that are followed within the center.
Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies and other regulations is applicable.
Tracked inventory, conducted cycle counts and audits and resolved issues to maintain accurate records.
Oversaw annual store budget while working closely with corporate and financial departments on reporting and payroll.
Taught junior employees how to meet operational and sales goals with proactive strategies.
Established, enforced and optimized
departmental procedures and goals to optimize team performance and productivity.
Identified appropriate solutions to minimize issues and quickly solve problems.
Company Making a Difference Award