QUALITY ASSURANCE SPECIALIST

Life Sera, a Life Therapeutics Company, has an exciting opportunity for a Quality Assurance Specialist at our Charlotte Donor Center.

 

The incumbent's responsibilities are to:

  Ensure the center maintains compliance in the areas of proper documentation and record retention in relation to ISO, FDA, cGMP, and SOP in the following areas: Equipment maintenance and calibration performed correctly and on time. External sample and product shipment releases and shipping records.  Responsible for attesting that release protocols are followed. Ensuring that employees have proper training and approval documentation for the work they perform. Center incident documentation including using exceptions reporting system.

 Assure the information in donor record files and other manufacturing records is documented

according to instructions in the Company SOPs.

 Verify that nonconforming product is disposed of properly, lookbacks are performed correctly and

Timely and proper documentation is performed.

 Assure that QC checks on equipment, reagents and records have been performed as required and are in acceptable ranges.

 Perform audits for self-assessment evaluation, monitor records and overall compliance related to the company quality systems.

Assure that all internal and external audits are performed, documented, and/or reviewed and closed.

 Assure that the most recently approved procedures and forms are in the center procedure manuals.

Assist in maintaining the established quality system under the ISO 9002 guidelines and help ensure that all operations in the center are in compliance with the Company?s Quality Program.





 Assist in or conduct and evaluate center training and orientation programs.

 Co-host center audits.

 

Postion Requirements:

 

1. High school diploma or equivalent.

2. Must have a minimum of one year work experience in a donor center and a minimum of one year of quality assurance experience in biologics.

3. Must have legible handwriting.

4. Must possess knowledge and aptitude to learn computer software such as Microsoft Word, Excel or other related software programs.

5. Must have adequate communication skills and be able to effectively communicate with people of all levels.

6. Must have excellent organizational skills and be detail oriented.

 

We offer a competitive compensation and benefits package. For immediate consideration, please forward your resume with cover letter and salary expectations in a Microsoft Word format to Jobs@Life-Therapeutics.com quoting reference number ?QAS CharlotteJune06? in the subject line.  You may also fax your resume using the above codes to our Atlanta office at 404-300-5301.

 

To learn more about Life Therapeutics, go to www.Life-Therapeutics.com.  Life Therapeutics is an Equal Opportunity Employer.