Quality Assurance Specialist

7 days ago


Burlington, Vermont, United States CSL Full time
Job Title: Quality Specialist

About the Role

This is an exciting opportunity to join CSL as a Quality Specialist, where you will play a key role in ensuring the quality and compliance of our products and processes. As a Quality Specialist, you will be responsible for monitoring and improving the quality of our products, as well as ensuring compliance with regulatory requirements.

Key Responsibilities

  • Perform final QA review and release for all shipments and associated documents to ensure they meet customer specifications.
  • Ensure center records QA review to ensure thoroughness, accuracy, and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies.
  • Maintain and review Plasma center personnel training documents to ensure they comply with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements.
  • Collaborate with center management 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.

Requirements

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

Working Conditions

(Physical and 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 manual dexterity
  • See and speak with customers and observe equipment operation
  • Occasionally be required to lift and carry 25 lbs.

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.



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