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Lab Quality Assurance Analyst
Octapharma Plasma, Inc. | Charlotte, North Carolina
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Job Description

Quality Assurance – Regulatory - Analysis


We are seeking a Lab Quality Assurance Analyst to assist in opening our new, state of the art laboratory. This lab is slated to test over 4 million samples annually. Reporting into the Supervisor, Lab Quality Assurance, this position provides quality assurance review and release of laboratory test results and all associated processes 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.

Additional responsibilities of the Lab QA Analyst role include:

        Perform routine review of automated and manual test results and quality data and related documents for release of test results.

        Notify donor centers of repeat reactive (RR) viral marker testing according to OPI SOP requirements. 

        Obtain RR donor information from donor centers and enter donor information into NDDR per SOP requirements.

        Ensures that the acceptance criteria have been met for all incoming laboratory reagents, QC material, or raw materials and that OPI procedures have been followed for receiving and labeling them.

        Perform review and release of instrument maintenance, and calibration records.  Assist in the management of maintenance and calibration schedules for all equipment.

        Ensure that proficiency testing is performed as scheduled, scored results are reviewed in a timely manner and corrective actions are taken for scores less than 100%.

        Ensure that corrective and preventative action (CAPA) plans are implemented and effective.

        Assist with the development and implementation of corrective actions in response to internal, customer, and regulatory inspection observations.  Document risk assessment for out-of-specifications test results or equipment.

        Perform tracking and trend analysis for laboratory processes and provide periodic reports as required.

        Assist with the training of staff on Quality Assurance and Good Manufacturing Practices (GMP) procedures.

        Assist with the development, review and execution of software and equipment validation protocols.

        Perform Quality receipt, review and release of plasma product.

Quality Assurance – Regulatory - Analysis


Qualified candidates of this role must offer a Bachelor’s or Associate’s degree in a biological science or related field. An ASCP certification (or eligibility) is preferred. You must be self-motivated with the ability to work with minimal supervision. You must offer strong organizational skills, attention to detail and excellent interpersonal skills.

Other requirements of the Lab Quality Assurance Analyst role include:

        3 years' experience in a FDA regulated laboratory facility, preferred. 

        Knowledge of plasma/blood bank industry procedures is highly preferred.

        1 year testing experience in a chemistry department preferred.

        1 year in a Quality Assurance role preferred.

        Proficient with computer software in an office and laboratory environment. 

        Ability to read, understand, write, and follow SOPs, validation protocols, etc. and to complete documentation in a clear, accurate manner.

        Ability to work diverse shifts and overtime, as required.


Quality Assurance – Regulatory - Analysis


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 include:

        Medical, Dental and Vision Insurance

        Life Insurance

        401(k) contribution and matching program

        Flexible Spending Accounts

        Tuition Reimbursement

        Team-oriented environment

        Recognition programs


Quality Assurance – Regulatory - Analysis

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

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