Apr 25, 2019
This position should not be involved in manufacturing activities and must be independent from production with no additional responsibilities. Responsible for establishing and implementing effective Quality systems. • Ensures the activities and controls used to determine the accuracy and reliability of the establishments’ personnel, equipment, reagents and operations in the manufacturing of blood products including testing and product release • Collaborate with center management to ensure compliance with all relevant regulations, laws, standards and Company policies, and that the Center is “inspection ready” at all times • Lead quality team to ensure all staff is competently performing their duties as evidenced by findings of a program of monitoring, tracking and trending of key metrics • Responsible for hiring, retention and development of quality staff • Lead investigations to determine root causes, corrective/preventative actions and appropriate coordination/leadership of process improvements • Proactively facilitate communication and interdepartmental coordination quality issues and host audits
1 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.
2 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.
3 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.
4 Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality. Working knowledge of the change management process and appropriately raise ideas for consideration for change locally and upward to quality and area management.
5 Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies.
6 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 audits timely. Utilize quality tools and applications to facilitate understanding of issues and documentation.
7 Maintain clean efficient work environment and ensures sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions.
8 Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same.
9 Comply with all federal, state and local regulatory and company policies and procedures.
10 Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance.
11 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable.
12 Lead investigations and deviations to determine root cause, correction/preventative actions and effectiveness checks. Monitor CAPA’s and effectiveness checks to ensure issues are resolved.
13 Perform other job-related duties as assigned.
Bachelor’s Degree preferred
Equivalent combination of education and professional work experience required
Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR
1 year Quality experience (CSA/CSAb) required OR
Completion of CSL Plasma Leadership Development program
Maintain company Technical Training certification
Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations
Monitor and manage entire financial responsibility of the center
Proficient in English
(physical & mental requirements)
Ability to make decisions which have significant impact on the department’s creditability, operations and services
Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations
Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens
Overnight travel required up to 10% of the time
Generally spends 80% of the time standing and walking and 20% of time sitting
Occasionally lift and carry up to 25 lbs.
Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors
Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc.
Required to wear Personal Protective Equipment while performing specific tasks or in certain areas
Fast paced environment with frequent interruptions
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.
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