Experience:
No experience
Employment Type:
Full time
Posted:
2/14/2018
Job Category:
Health Care Provider
Industry:
Other
Laboratory Quality Assurance Manager
(This job is no longer available)
Octapharma Plasma, Inc. | Charlotte, NC
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Job Description

Laboratory – Quality Assurance - Leadership

 

We are seeking a Laboratory Quality Assurance Manager to support our new, state of the art laboratory. This lab is slated to test over 4 million samples annually. Reporting into the Sr. Director of Regulatory Affairs and Quality Assurance, this position will lead the Quality Assurance function of the facility in accordance with approved SOPs and international, federal, and local regulations including the Clinical Laboratory Improvement Act (CLIA), applicable Codes of Federal Regulations, and other designated laws and authorities.

Additional responsibilities of the Laboratory Quality Assurance Manager role include:

        Ensures that quality activities and manufacturing records are in compliance with SOPs and regulatory requirements; determines the need for corrective actions, ensures proper documentation; determines effectiveness of the action.

        Advises other management team members and staff regarding daily quality assurance/quality control issues affecting sampling suitability, product quality, product release and shipment and resolution of same; develops and implements corrective actions.

        Leads the facility employee training plan and modules in accordance with regulatory requirements. 

        Trains laboratory and plasma warehouse staff on Quality and cGMP procedures.

        Writes and reviews laboratory and plasma warehouse SOPs for implementation. 

        Represents the Lab and Plasma Warehouse on the Change Control Board for process changes that may impact laboratory quality systems. 

        Performs final QA review and release of donor test results and plasma products to ensure test results and product meet customer and regulatory specifications.

        Performs regular quality compliance audits of the facility activities, i.e. manufacturing records, sample processing, testing and release. 

        Provides direction and oversight of QA staff to ensure required quality tasks are completed within defined time frames.

        Prepares staff and co-hosts both internal and external audits.  Collaborates with the Laboratory Director to complete all audit responses.

        Develops, implements and analyzes tracking and trending data for lab and warehouse process exceptions.

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

        Writes and reviews software and equipment validation protocols, as required.

        Documents risk assessment for out-of-specifications test results or equipment.

        Promotes continuous improvement and quality awareness by introducing on-going improvement programs.


Laboratory – Quality Assurance - Leadership


 


Qualified candidates of this role must offer a Bachelor’s degree in a life science. Medical Technologist as well as ASQ certifications are preferred. You must offer strong organizational skills, attention to detail and excellent interpersonal skills.


Other requirements of the Laboratory Quality Assurance Manager role include:


        5+ years work experience in the biologics industry, preferably in a laboratory setting


        3+ years of quality assurance related work experience


        3+ years supervisory experience


        2+ years experience developing SOPs and procedures


        Experience working in an FDA and cGMP regulated facility highly preferred


        Experience in a lab production environment preferred


        Experience hosting inspections from a regulatory agency preferred


        Demonstrated proficiency with Microsoft Office suite


        Must have strong communication skills and be able to effectively communicate with people of all levels


        Ability to interpret SOP’s and regulatory requirements


        Ability to make decisions impacting the product and sample safety based on independent judgment and discretion


        Must be willing and able to obtain certification as a QA Trainer


 



Laboratory – Quality Assurance - Leadership


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 include:


        Medical, Dental and Vision Insurance


        Life Insurance


        401(k) contribution and matching program


        Flexible Spending Accounts


        Tuition Reimbursement


        Team-oriented environment


        Recognition programs


 



Laboratory – Quality Assurance - Leadership



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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