**Responsibility**:- Perform according to valid procedures, as required:Carry out Incoming Goods Inspection when necessaryCleaning and sanitation of Laboratory / QC areas.Perform QC Inspections on the Manufacturing floor.Issue a QIR for non-conforming product.Carry out QC testing and examination- Training: Training of new hires on inspection, specification and other product requirements when necessary (QC Operator I BSc)- Product Evaluation: Inspect / test non-conforming product to resolve QIR issues when necessary. Restriction of non-conforming product according to appropriate QMI documents (physical and SAP).- Administrative: Review batch (DHR) records while in production. Assist in routine inventory (e.g., supplies, etc) for labs.- Technical: Assist in technical complaint investigation, corrective actions, when requested.- Assist in validation requirements including required visual inspections, as well as assisting in dimensional measurements when requested- Assist in the administration of the Computer Aided Quality CAQ system, as needed- Collect and maintain retain samples of required products- Other duties as assigned**Authority**:- Evaluation and release of products into production according to valid QMI documents.- Restriction of non-conforming product according to appropriate QMI documents (physical and SAP).- Release incoming goods according to valid Certificate of Analysis, TP's and SOP's as required.(e.g., raw materials, trays, labels) when requested.- Training of new or existing QC employees regarding QC procedures and use of equipment.- Assist in data input into the CAQ- Communication and information exchange between Quality, Production BioScience or other departments within facility as needed. Communication and information exchange with affiliated Greiner facilities.**Job Requirements**:- High school education or equivalent; Degree is preferred with at least 1 year of relevant work experience.- Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred- Must have sufficient communication and writing skills.- Basic computer knowledge and MS office skills.- Basic GMP and GDP knowledge and experience preferred- Basic knowledge of statistic and calculations preferred- Must pass pre-employment test.**Physical Requirements**:- Must be able to stand and walk for up to 12 hours.- Must be able to lift up to 70 lbs.- 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.
