Quality Specialist

hace 1 semana

Chihuahua Chih, México CSL Plasma Inc. A tiempo completo

locations Americas, US-UT, Salt Lake 627, CSL Plasma

time type Full time

posted on Posted Yesterday

job requisition id R

The Opportunity

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

  • Reporting compliance status data to operational quality management
  • Collaborate with center management in the development and implementation of continuous improvement plans
  • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns
  • Responsible for coordinating and managing training activities, policies and processes at the center level.

You will report to the Assistant Manager Quality

The Role

  • Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.
  • Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
  • Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action.
  • Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements.
  • Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.
  • Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
  • Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues.
  • Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.
  • Identifying and communicate non-conformities to CSL's SOP's. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation.
  • Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.
  • Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers.
  • Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective.
  • Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable.
  • Follow all Standard Operating Procedures (SOPs), company policies and procedures.
  • Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA.
  • Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
  • Assist Plasma center staff in completing other special projects or assignments, as requested.
  • Perform other job-related duties, as 4-6 key responsibilities of the job

Your skills and experience

Education

High school diploma or equivalent required. Associate or Bachelor's degree in business administration or biological sciences preferred.

Experience

  • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment.
  • Strong critical reasoning, decision-making and problem solving skills to analyze situations
  • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
  • Understand Quality Systems and/or regulated training requirements

Working Conditions

(physical & mental requirements)

  • Occasionally required to work with the public when they are dissatisfied
  • 80% of the time standing and walking and 20% of the time sitting
  • Reach, bend, kneel and have high level of manual dexterity
  • See and speak with customers and observe equipment operation
  • Occasionally be required to lift and carry 25 lbs.
  • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors

CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit .

About CSL Plasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma .

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Plasma Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here .

#J-18808-Ljbffr

  • Engineering Specialist Quality

    hace 2 meses

    Chihuahua, México Ford Motor Company A tiempo completo

    Engineering Specialist Quality Responsible for leading QOS initiatives within the launch department. - Review Quality deliverables with production team leaders and Process Coaches based on quality issues, be the point of contact with other departments such as Machining, Quality and MP&L. - Keep traceability records regarding quality actions for PTR. - Manage...

  • Engineering Specialist Quality

    hace 2 días

    Chihuahua, México Ford Motor Company A tiempo completo

    Engineering Specialist Quality Responsible for leading QOS initiatives within the launch department. - Review Quality deliverables with production team leaders and Process Coaches based on quality issues, be the point of contact with other departments such as Machining, Quality and MP&L. - Keep traceability records regarding quality actions for PTR. - Manage...

  • Engineering Specialist Quality

    hace 7 días

    Chihuahua, Chihuahua, México Ford Motor Company A tiempo completo

    Engineering Specialist QualityResponsible for leading QOS initiatives within the launch department. Review Quality deliverables with production team leaders and Process Coaches based on quality issues, be the point of contact with other departments such as Machining, Quality and MP&L. Keep traceability records regarding quality actions for PTR. Manage...

  • Experienced Supplier Quality Specialist

    hace 3 semanas

    Chihuahua, México BOEING A tiempo completo

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for...

  • Experienced Supplier Quality Specialist

    hace 3 semanas

    Chihuahua, México BOEING A tiempo completo

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for...

  • Senior Supplier Quality Specialist

    hace 2 semanas

    Chihuahua, México BOEING A tiempo completo

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re committed to fostering an environment for every teammate that’s welcoming, respectful and inclusive, with great opportunity for...

  • Experienced Supplier Quality Specialist

    hace 1 semana

    Chihuahua, Chihuahua, México BOEING A tiempo completo

    At Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for...

  • Experienced Supplier Quality Specialist

    hace 3 semanas

    Chihuahua, México Boeing A tiempo completo

    Job Description Qualifications: Boeing Mexico Service Company is seeking a highly motivated Supplier Quality Specialist , reporting to the Supplier Quality Senior Manager, working out of the Chihuahua, Mexico office. The Supplier Quality Specialist will join our Supplier Quality Intervention and Recovery team to drive improvements in Supplier...

  • Experienced Supplier Quality Specialist

    hace 7 días

    Chihuahua, Chihuahua, México The Boeing Company A tiempo completo

    Job DescriptionAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great...

  • Quality Specialist

    hace 1 semana

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    locations Americas, US-UT, Salt Lake 627, CSL Plasma time type Full time posted on Posted Yesterday job requisition id R The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state,...

  • Quality Specialist

    hace 7 días

    Chihuahua, Chihuahua, México Csl Plasma Inc. A tiempo completo

    locations Americas, US-ME, South Portland 256, CSL Plasma time type Full time posted on Posted 21 Days Ago job requisition id R The Opportunity This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local,...

  • Sr. Spec, Quality Assurance

    hace 7 días

    Chihuahua, Chihuahua, México Cardinal Health, Inc. A tiempo completo

    What Quality Assurance contributes to Cardinal HealthQuality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...

  • Sr. Spec, Quality Assurance

    hace 7 días

    Chihuahua, Chihuahua, México Cardinal Health, Inc. A tiempo completo

    What Quality Assurance contributes to Cardinal HealthQuality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and...

  • Recruitment & Selection Specialist

    hace 3 semanas

    Chihuahua, México Iochpe-Maxion A tiempo completo

    Maxion Division: Maxion Wheels- Date: Jul 6, 2023- Location: Chihuahua, MX**Recruitment & Selection Specialist**: As the largest manufacturer of wheels for the global marketplace, Maxion Wheels is continually seeking motivated individuals who have what it takes to make a positive impact on our business and our customers. Our long history, and our products,...

  • Recruitment & Selection Specialist

    hace 7 días

    Chihuahua, Chihuahua, México Iochpe-Maxion A tiempo completo

    Maxion Division: Maxion Wheels- Date: Jul 6, 2023- Location: Chihuahua, MXRecruitment & Selection Specialist:As the largest manufacturer of wheels for the global marketplace, Maxion Wheels is continually seeking motivated individuals who have what it takes to make a positive impact on our business and our customers. Our long history, and our products,...

  • Specialist- Production Control

    hace 5 días

    Chihuahua, México Ford Motor Company A tiempo completo

    **Position Duties** - Confirm packaging meets form, fit and ergonomic requirements for plant internal packaging/dunnage. - Initiate corrective actions to alleviate part quality concerns related to dunnage or handling - Support lean manufacturing continuous improvement (decanted marketplace, small lot containerization, flexible linefeed, returnable...

  • Legal Specialist

    hace 2 semanas

    Chihuahua, México BairesDev A tiempo completo

    BairesDev is proud to be the fastest-growing company in America. With people in five continents and world-class clients, we are only as strong as the multicultural teams at the heart of our business. To consistently deliver the highest quality solutions to our clients, we only hire the Top 1% of the best talents and nurture their professional growth on...

  • Specialist- Production Control

    hace 1 semana

    Chihuahua, Chihuahua, México Ford Motor Company A tiempo completo

    Position Duties Confirm packaging meets form, fit and ergonomic requirements for plant internal packaging/dunnage. Initiate corrective actions to alleviate part quality concerns related to dunnage or handling Support lean manufacturing continuous improvement (decanted marketplace, small lot containerization, flexible linefeed, returnable containerization,...

  • Broadband Trabajos En México

    hace 1 semana

    Chihuahua, Chihuahua, México CommScope A tiempo completo

    As a Specialist - Technology Support Services, you will be the trusted advisor and technical support professional for the Wesco Global Solutions business. The Technology Support Services team is the first tier of support in allPosition Title: Supervisor Technical QA Broadband: 1B Reports to Title: Quality Assurance Manager Job code: Dept / Function: Quality...

  • Engineering Specialist Process

    hace 1 semana

    Chihuahua, Chihuahua, México Ford Motor Company A tiempo completo

    Support Manufacturing Process Engineering activity for Chihuahua Engine Plant Drive continuous improvement in safety, quality and productivity Provide plant linkage to Product Design and Manufacturing Engineering for manufacturing related changes Lead small programs from cost study to product delivery Develop action plans as required to investigate and...