Experience:
3-5 years of experience
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Employment Type:
Full time
Posted:
3/29/2018
Job Category:
Health Care Provider
Industry:
Other
Lab Quality Assurance Supervisor
(This job is no longer available)
Octapharma Plasma, Inc. | Charlotte, NC
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Job Description

Lab QA Supervisor – Quality Assurance - Regulatory

Job Responsibilities

We are seeking a Lab QA Supervisor to assist in supporting our new, state of the art laboratory. This lab is slated to test over 4 million samples annually. Reporting into the Manager of Lab & Plasma Storage QA, this position will provide QA supervision for all laboratory departments including Sample Management, Viral Marker and Chemistry Testing, Blood Bank, Immunogen Red Blood Cell Laboratory, Plasma Storage, and related supply management.  The Lab QA Supervisor will have direct responsibility for the QA Analysts. Moreover, this person will supervise the quality review and release of laboratory test results and all associated processes. 

Additional responsibilities of the Lab QA Supervisor role include:

  • Assist in developing training modules and with the training of laboratory testing and QA Analyst staff on Quality Assurance and GMP procedures.
  • Ensures staff compliance with the OPI Quality Assurance program including the receiving, labeling, testing, and acceptance criteria for all laboratory incoming reagents or raw materials.
  • Ensure that the performance of reviews of quality control data, calibration records, and donor sample test results have been completed allowing for the release of donor test results in a timely manner.
  • Assist in the hosting of internal, customer, and regulatory audits.  Perform periodic internal audits of quality control records, calibrations, training, test data batch documentation, etc. Assist in the development of responses to internal, customer, and regulatory inspection observations.
  • Assist with management of the error management system by performing investigations of variations, deviations and risk assessments for out-of-specifications test results or equipment.  Ensure corrective and preventative action (CAPA) plans are implemented and effective.  Perform tracking and trending analysis for laboratory processes and for monitoring key performance indicators.
  • Assist with the Quality receipt, review and release of plasma product.

 

Lab QA Supervisor – Quality Assurance - Regulatory

Job Requirements

Qualified candidates of this role must offer an Associate’s degree or a Bachelor’s degree. A degree focus in a life science field is preferred. You must offer excellent organizational skills, attention to detail and strong interpersonal skills. You must be self-motivated and flexible to take on changing priorities.

Other requirements of the role include:

  • 5+ years’ experience in a FDA regulated facility.
  • 1+ year(s) in a Quality Assurance role preferred.
  • Previous experience in a team lead or supervisory role highly preferred.
  • Ability to read, understand, write, and follow SOPs, validation protocols, etc. and to complete documentation in a clear, accurate manner.
  • Ability to be on call and to work diverse shifts and overtime hours, as required. 

Lab QA Supervisor – Quality Assurance - Regulatory

Benefits

At Octapharma Plasma we believe in our employees who have the passion and ability to make a difference to the quality of life of their communities. The individual growth and success of each and every employee at Octapharma Plasma is an integral part of our continued growth and success. We offer competitive compensation and a comprehensive benefits package.

Other benefits of the Supervisor role include:

·         Medical, Dental and Vision Insurance

·         Life Insurance

·         401(k) contribution and matching program

·         Flexible Spending Accounts

·         Tuition Reimbursement

·         Team-oriented environment

·         Recognition programs

 

Lab QA Supervisor – Quality Assurance - Regulatory

About Octapharma Plasma, Inc.

We believe the growth and success of each of our employees is an important part of the continued growth and success of our company. We create a workplace known for teamwork and recognition based on the following values: Customer Focus Leadership Integrity Team Spirit Self Respect Respect for Others Life Balance Safety