Quality Specialist

2 weeks ago

San Francisco, California, United States CSL Full time

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, SOPs, 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 CSLs SOPs. 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 Bachelors 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 customer service skills
  • 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
Our Benefits

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 CSLs 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 CSLPlasma

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

  • Quality Specialist

    2 weeks ago

    San Ramon, California, United States ATLAS Lift Tech Full time

    POSITION OVERVIEW: The Quality Specialist will be expected to use training, experience, and good judgement to perform tasks assigned in the Quality Department. JOB RESPONSIBILITIES: Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items. Assist Complaint program at Atlas Lift Tech including...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Noblis Full time

    Noblis Mission Solutions Division (MSD) provides Naval lifecycle management, engineering, enterprise transformation and program management support. Noblis MSD's engineers, developers, technical staff, programmers, analysts, and program managers ident Quality Assurance, Assurance, Specialist, Mechanical, Quality Control, Engineer, Technology

  • QC Specialist

    2 weeks ago

    San Francisco, California, United States Ultradent Full time

    QC Specialist The Quality Control Specialist is responsible for assigning and maintaining deviations in regard to non-conforming products by auditing the manufacturing and inspection processes, reviewing the quality documents related to the manufactu Continuous Improvement, QC, Quality Control, Specialist, Control Specialist

  • Quality Complaints Management Specialist

    2 weeks ago

    San Diego, California, United States LinkedIn - Jobboard Full time

    Position : Quality Complaints Management Specialist Location : San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st Shift Client: Medical Device Company Job Category: Healthcare Level Of Experience: Mid-Level Employment Type: Contract on W2 (Need US Citizens or GC Holders Only) Work hours: 8:30 - 5 M-F Job Description The Specialist, Clinical...

  • Quality Assurance Specialist

    2 weeks ago

    San Jose, California, United States Kymanox Full time

    You want to make a difference and have an impact You enjoy having an influence in your day to day work You are motivated by working alongside a team filled with subject matter experts that will help you learn and grow You wake up every day and do what you do If this sounds like you, youve come to the right place. Kymanox is hiring a Quality Assurance...

  • Care Specialist

    4 weeks ago

    San Francisco, California, United States Upward Health Full time

    CARE SPECIALIST - ECMAre you a dedicated individual with a passion for providing quality care and making a positive impact in the lives of others? If you possess a unique blend of skills and attributes, including critical thinking, resilience, and the ability to thrive in unstructured environments, we invite you to consider joining our team as a Care...

  • Care Specialist

    4 weeks ago

    San Francisco, California, United States Upward Health Full time

    CARE SPECIALIST - ECMAre you a dedicated individual with a passion for providing quality care and making a positive impact in the lives of others? If you possess a unique blend of skills and attributes, including critical thinking, resilience, and the ability to thrive in unstructured environments, we invite you to consider joining our team as a Care...

  • Care Specialist

    4 weeks ago

    San Francisco, California, United States Upward Health Full time

    CARE SPECIALIST - ECMAre you a dedicated individual with a passion for providing quality care and making a positive impact in the lives of others? If you possess a unique blend of skills and attributes, including critical thinking, resilience, and the ability to thrive in unstructured environments, we invite you to consider joining our team as a Care...

  • Care Specialist

    2 months ago

    San Francisco, California, United States Upward Health Full time

    CARE SPECIALIST - ECMAre you a dedicated individual with a passion for providing quality care and making a positive impact in the lives of others? If you possess a unique blend of skills and attributes, including critical thinking, resilience, and the ability to thrive in unstructured environments, we invite you to consider joining our team as a Care...

  • Care Specialist

    4 weeks ago

    San Francisco, California, United States Upward Health Full time

    CARE SPECIALIST - ECMAre you a dedicated individual with a passion for providing quality care and making a positive impact in the lives of others? If you possess a unique blend of skills and attributes, including critical thinking, resilience, and the ability to thrive in unstructured environments, we invite you to consider joining our team as a Care...

  • Health System Specialist

    7 days ago

    San Francisco, California, United States Veterans Health Administration Full time

    The Health System Specialist is expected to have a broad knowledge of healthcare management systems and principles relating to these areas. To accomplish these functions the Health System Specialist must adopt the principles, practices, processes, and techniques common to any general administrative situation to the specialized requirements of the Service....

  • Temp Senior Quality Control Specialist

    2 weeks ago

    South San Francisco, California, United States CytomX Therapeutics Full time

    Temp Senior Quality Control Specialist Headquarters Location: South San Francisco, CA Candidate Location: Hybrid Travel Required: 5% Reports To: Director, Quality Control Department: Quality Control Position Type: Temporary, 40 hours per week, (8 months), Non-Exempt About CytomX Therapeutics: CytomX Therapeutics, Inc. is committed to changing the treatment...

  • Activity Specialist

    4 weeks ago

    San Francisco, California, United States Sage Eldercare Solutions Full time

    Activity SpecialistJob Location: Contra Costa County, CA; Various East Bay Area, CA locations. Requires on-site work in residences and facilities and remote collaboration with team members.Job Schedule: Part-time to Full-timeReports to: Hummingbird Project ManagerAre you driven by a passion to make a meaningful impact in the lives of elders through creative...

  • Activity Specialist

    4 weeks ago

    San Francisco, California, United States Sage Eldercare Solutions Full time

    Activity SpecialistJob Location: Contra Costa County, CA; Various East Bay Area, CA locations. Requires on-site work in residences and facilities and remote collaboration with team members.Job Schedule: Part-time to Full-timeReports to: Hummingbird Project ManagerAre you driven by a passion to make a meaningful impact in the lives of elders through creative...

  • Activity Specialist

    1 month ago

    San Francisco, California, United States Sage Eldercare Solutions Full time

    Activity SpecialistJob Location: Contra Costa County, CA; Various East Bay Area, CA locations. Requires on-site work in residences and facilities and remote collaboration with team members.Job Schedule: Part-time to Full-timeReports to: Hummingbird Project ManagerAre you driven by a passion to make a meaningful impact in the lives of elders through creative...

  • Activity Specialist

    1 month ago

    San Francisco, California, United States Sage Eldercare Solutions Full time

    Activity SpecialistJob Location: Contra Costa County, CA; Various East Bay Area, CA locations. Requires on-site work in residences and facilities and remote collaboration with team members.Job Schedule: Part-time to Full-timeReports to: Hummingbird Project ManagerAre you driven by a passion to make a meaningful impact in the lives of elders through creative...

  • Community Specialist

    2 weeks ago

    San Francisco, California, United States Felton Institute Full time

    Job Description Job Description Community SpecialistBehavioral Health ICM for Older Adults Agency OverviewFounded in 1889, Felton Institute/Family Service Agency of San Francisco has a 129-year history of innovation in services for vulnerable children, families, and adults. Our mission is to strengthen families by providing caring, effective, and innovative...

  • Delivery Specialist

    2 weeks ago

    San Francisco, California, United States FoodRocket Inc Full time

    ???? **Privacy Notice** **Delivery Specialist (Part-time) $500 Sign-on Bonus** San Francisco, California / Operations / Part Time **Description** Food Rocket is a quick-commerce application that provides fee-free, on-demand 10-15 minute grocery deliveries from our strategically placed dark stores directly to our customers by using e-bikes and e-scooters. We...

  • Litigation Docketing Specialist

    2 weeks ago

    San Francisco, California, United States Debevoise & Plimpton Full time

    LITIGATION DOCKETING SPECIALIST (San Francisco) MANAGING ATTORNEYS OFFICE Debevoise & Plimpton LLP is a premier law firm with market-leading practices and a global perspective. Our clients look to us to bring a distinctively high degree of quality, intensity and creativity to resolve legal challenges effectively and cost efficiently. We believe in hiring...

  • Program Specialist

    2 weeks ago

    San Francisco, California, United States CYCSF Full time

    JOB ANNOUNCEMENTThe Community Youth Center of San Francisco (CYC) provides the youth of our city a sense of belonging and vital tools and experiences to succeed in life. Our services include academic support and college counseling, job placement and employment training, substance use and violence prevention education, crisis intervention and mediation,...