Quality control Document Specialist

Job Title:

Quality Control Documentation Specialist

Responsibility:

·    Review device history records (DHRs) and associated QC test records for completeness and verify accuracy of the records

·    Provide compliance reviews of Incoming Goods Inspection Forms, Equipment logbooks,Test Records, Quality Irregularity Reports, Solution Prep documentation, and Laboratory notebooks for Quality Control. 

·    Collaborate with QC and Production to resolve DHR discrepancies or errors as related to Good Documentation Practices , SAP inventory, or product release to market

·     Organizing, filing, and archiving DHRs, QIRs, and other quality records

·     Preparation, editing and publishing of test procedures, standard operating procedures, and other applicable quality documents. 

·     Support special projects for QC Preanalytics and QC Bioscience as assigned

·     Other duties as assigned

Authority:

 

·     Edit, update, and maintain relevant procedures for quality department according to quality guidelines.

·     Review and approval of QC Documentation

·     Communication and information exchange with affiliated Greiner facilities.

·     Training of QC employees regarding QC procedures and documentation.

·     Functions related to SAP QM module Key User

Job Requirements:

 

·     Minimum high school diploma; Bachelor’s Degree in life sciences or related field is preferred

·     At least 3 years of experience in FDA regulated manufacturing facility, quality position preferred

·     Demonstrate knowledge of a quality management system

·     Must have sufficient communication and writing skills.

·     Must pass pre-employment test.

·     Must have basic computer knowledge and MS office skills.

Physical Requirements:

·     Must be able to stand and walk for up to 8/12 hours.

·     Must have appropriate vision to perform detailed quality         inspection as outlined in SOPs and TPs.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.

 

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