PortArthurRecruiter Since 2001
the smart solution for Port Arthur jobs

Assistant Manager of Quality

Company: CSL Behring
Location: Port Arthur
Posted on: November 30, 2019

Job Description:

About CSLWith operations in 35+ nations and - 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job Description--- 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.--- 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.--- 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.--- 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.--- 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.--- 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.--- Comply with all federal, state and local regulatory and company policies and procedures.--- 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.--- Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable.--- 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.--- Perform other job-related duties as assigned.Education--- Bachelor's Degree preferred--- Equivalent combination of education and professional work experience requiredExperience--- 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 programAdditional Comments--- 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 EnglishWorking Conditions(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 interruptionsAll 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.--- Bachelor degree in scientific discipline/life sciences or related discipline--- 5+ years' experience related to quality and regulatory/ Plasma industry experience--- Demonstrated leadership/supervisory experience--- Knowledge of government and industry regulations#CB

Keywords: CSL Behring, Port Arthur , Assistant Manager of Quality, Executive , Port Arthur, Texas

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Utilization Manager
Description: Utilization Manager - Field/Remote Position Purpose: Perform duties to authorize and review utilization of mental health and substance abuse services provided in inpatient, outpatient and intermediate (more...)
Company: Centene
Location: Houston
Posted on: 12/10/2019

Associate Vice President for Development
Description: Position Summary Reporting to and working with the vice president for Development and Alumni Relations, the associate vice president provides leadership, evaluation, and mentoring to the individual giving (more...)
Company: Rice University
Location: Houston
Posted on: 12/10/2019

Nurse Manager - Mother Baby (RN)
Description: Description SHIFT: No Weekends br br SCHEDULE: Full-time br br Do you want to be a part of a family and not just another employee Are you looking for a work environment where diversity and inclusion (more...)
Company: HCA Houston Healthcare Clear Lake
Location: Webster
Posted on: 12/10/2019


Project Manager
Description: Position Title: Project Manager -Location: Houston, TX -Gulf Interstate Engineering provides quality project management, engineering and design, GIS, materials management, and construction management (more...)
Company: Gulf Interstate Engineering
Location: Houston
Posted on: 12/10/2019

Nurse Manager - Labor & Delivery (RN) (L&D)
Description: Description SHIFT: No Weekends br br SCHEDULE: Full-time br br Do you want to be a part of a family and not just anotheremployee Are you looking for a work environment where diversity and inclusionthrive (more...)
Company: HCA Houston Healthcare Clear Lake
Location: Webster
Posted on: 12/10/2019

IT Infrastructure Project Manager (25767)
Description: The IT Infrastructure Project Manager is responsible for planning and executing project work in support of UTMB---s Infrastructure software and hardware related projects. This position works with IT Leadership (more...)
Company: University of Texas Medical Branch
Location: League City
Posted on: 12/10/2019

Director of Opioid Crisis Response
Description: Arnold Ventures is a philanthropy whose core objective is to maximize opportunity and minimize injustice. We are dedicated to tackling some of the most pressing problems in the United States. We invest (more...)
Company: Arnold Ventures
Location: Houston
Posted on: 12/10/2019

Learning and Development Manager
Description: The Learning and Development Manager is a key role to Insgroup's learning and development strategies and initiatives. This position provides guidance in the Firm's succession planning and talent development (more...)
Company: Insgroup, Inc.
Location: Houston
Posted on: 12/10/2019

Dealer Business Development Manager
Description: Summary: Want to join one of the nation's best employers Interested in providing small and medium sized businesses with solutions that make them grow Do you like serving customers and care about people (more...)
Company: Heartland Payment Systems
Location: Texas City
Posted on: 12/10/2019

Property Manager - Raintree Apartments (Pasadena)
Description: Currently accepting applications for an experienced
Company: Monument Property Management
Location: Pasadena
Posted on: 12/10/2019

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

Port Arthur RSS job feeds