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Quality Specialist

Salary: $47,440 per year - estimated ?
Location: Tulsa County, OK
Company: CSL Plasma
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Job Description Summary
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
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Job Description









10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.
11 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.
12 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.
13 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.
14 Follow all Standard Operating Procedures (SOPs), company policies and procedures.
15 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.
16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.
17 Assist Plasma center staff in completing other special projects or assignments, as requested.
18 Perform other job-related duties, as assigned.
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 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
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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CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision 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.
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care (https://www.cslplasma.com/careers/how-do-we-care-for-you-as-csl-plasma) at CSL.
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 (https://www.cslplasma.com/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 (https://www.cslplasma.com/careers/diversity-and-inclusion) at CSL.
Do work that matters at CSL Plasma!
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
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