Quality Assurance Associate

Job Description

• The Quality Assurance Specialist will work directly with validation project coordinators, technical area representatives and laboratory management

• Primary responsibilities are reviewing laboratory test protocols and reports, coordinating SOP document revisions, entering electronic training records, maintaining tracking spreadsheets and filing paper copies of laboratory records

• Reviewing laboratory testing protocols

• Verify that customer information from a questionnaire has been accurately and completely transcribed into a document template

• Reviewing lab testing reports. Verify that lab testing data based on the protocol guidance has been accurately captured in the report template

• Reviewing data tables and laboratory records

• Perform all function of a document controller and training administrator including, but not limited to, processing requests for new documents, revising existing documents, coordinating document validity reviews, entering information into the document and training databases and maintaining associated electronic and hard copy records

• Issue controlled documentation for laboratory test data packages

• Provide support as needed to administrative staff and validation project coordinators including scanning and filing documents, revising/editing documents, making photocopies and preparing customer mailings. 

Qualifications

• Proficient with Microsoft Word and Excel

• Attention to detail

• Document Proof Reading

• Excellent written and verbal communication skills

• Documentation preparation and review

• Worked in a laboratory

• Working knowledge of laboratory information databases

• Responsible for document control responsibilities

• Responsible for training record maintenance

• Experience handling corrective and preventive actions (i.e. CAPA)

• Experience with audits

• Equipment validation and calibration

• Lean and Six Sigma certification

• CQA, CQE or CBA 

• College education

Additional Information

Kind Regards

Ricky