Quality SpecialistCSL • Americas, US, TX, Mesquite 085, CSL Plasma
[error_messages.no_longer_accepting]
Quality Specialist
CSL • Americas, US, TX, Mesquite 085, CSL Plasma
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 assigned.dd 4-6 key responsibilities of the job 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 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
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
Your skills and experience
Education
High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred.
Experience
Working Conditions
(physical & mental requirements)
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 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.
[job_alerts.create_a_job]
Quality Specialist • Americas, US, TX, Mesquite 085, CSL Plasma
[internal_linking.related_jobs]
Are you looking for a career that offers both purpose and the opportunity for growth? Parkland Community Health Plan (PCHP) is a proud member of the Parkland Health family.PCHP is a Medicaid Manage...[show_more]
Union Technologies is reindustrializing Americas defense manufacturing base with a first-of-its-kind Factories-as-a-Stockpile model, integrating advanced robotics, manufacturing, and software into ...[show_more]
Quality Improvement Specialist- Health Plan.Are you looking for a career that offers both purpose and the opportunity for growth? Parkland Community Health Plan (PCHP) is a proud member of the Park...[show_more]
IMMEDIATELY HIRING! Quality Assurance Specialist FULL-TIME Opportunity in Dallas, TX.The responsibilities of this role, supporting our 14 CFR Part 145 Certified Repair Station, are detailed below.R...[show_more]
BUILDING A WORLD CLASS TEAM STARTS WITH YOU.At the heart of CSA Group is a vision : making the world a better, safer, more sustainable place.
It's been part of our mission for nearly one hundred year...[show_more]
Baylor Scott & White Health Job Opportunity.Here at Baylor Scott & White Health, we promote the well-being of all individuals, families, and communities.
Baylor Scott and White is the largest not-fo...[show_more]
As a Warehouse Quality Control Specialist, you will be responsible for assisting with warehouse operations and ensuring smooth logistics, including : organize inventory and ensure items are stored p...[show_more]
Aon has an opportunity available for a Surety Analyst!.Do you have a basic knowledge of Surety, bond issuance and execution and Surety bond management applications? Or are you organized, meticulous...[show_more]
Job Title : Java Full Stack Developer.Location : TechM US Texas Plano.Years of Experience : 5 7 Years.We are seeking a skilled Java Full Stack Developer with a strong background in telecom to join our...[show_more]
Salary Range : $60-75K per year.Supported by our vertically integrated .With more than 40 years in the industry, Conner continues to deliver reliable, tailored packaging solutions that meet the...[show_more]
Clinical Quality And Regulatory Lead.We are seeking a proactive and detail-oriented Clinical Quality & Regulatory Lead to join our growing clinical team.
This hybrid role blends operational oversigh...[show_more]
Earn up to $16 USD / hourly and work remotely and flexibly.Outlier, a platform owned and operated by Scale AI, is looking for.
If you're passionate about improving models and excited by the future of ...[show_more]
Job Title : Operations Supervisor - Warehouse Work Location Type : On-Site LSG Sky Chefs is one of the world's largest airline catering and hospitality providers, known for its outstanding repu...[show_more]
V2Soft is a global leader in IT services and business solutions, delivering innovative and cost-effective technology solutions worldwide since 1998.
We have headquarteerd in Bloomfiled Hills, MI and...[show_more]
Work hard, have fun! At Cerris Builders (formerly MW Builders), we believe in delivering quality craftsmanship while having fun along the way.
Our group of construction companies prides itself on ou...[show_more]
Mark Cuban Cost Plus Drug Company, PBC is committed to providing affordable medicines at fixed, transparent profit margins to help patients left behind by market and regulatory forces.We aim to end...[show_more]
Zentech is one of the leading and most highly certified U.Electronics Manufacturing Services (EMS) providers in North America.
We support original equipment manufacturers (OEMs) of medical devices, ...[show_more]
Sales QA Specialist Hybrid role in our Frisco, TX office At Lexipol, our mission is to create safer communities and empower the individuals on the front lines with market-leading content and techno...[show_more]
Quality Improvement Specialist- Health Plan
Parkland Health and Hospital System • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Supervisor
Union Tech • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Improvement Specialist- Health Plan
Parkland Health & Hospital System • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Assurance Specialist - Maintenance
Global Medical Response • Dallas, TX, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Certification Specialist for HVAC
CSA America Testing & Certification LLC • Dallas, TX, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Improvement Coordinator II
Texas Staffing • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Warehouse Quality Control Specialist
TradeJobsWorkforce • 75267 Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Surety Analyst
Aon • Dallas, TX, United States
[job_card.full_time] +1
[last_updated.last_updated_variable_days] • [promoted]
Sr. Analyst - Quality
Yantran LLC • Plano, TX, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Manager
Conner Industries Inc. • Garland, TX, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_30]
Clinical Quality and Regulatory Lead
Topography Health • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Remote Text Quality Evaluator
Outlier • Mesquite, TX, United States
[filters.remote]
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Manager, Quality Operations & Regulatory Affairs
LSG Sky Chefs • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Assurance Spec
V2Soft • Dallas, TX, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Control Specialist
Cornerstone Builders • Plano, TX, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Quality Director
Mark Cuban Cost Plus Drug Company, PBC • Dallas, TX, United States
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Quality Engineer
Zentech Manufacturing I • Richardson, Texas, United States, 75081
[job_card.full_time]
[last_updated.last_updated_30]
Sales QA Specialist
Lexipol LLC • Frisco, TX, US
[job_card.full_time]
[filters_job_card.quick_apply]
[last_updated.last_updated_variable_days]