· Provide support for all validation/qualification activities throughout the facility including new and existing products, process validation, equipment qualification, and software validation.
· Write, review, and execute protocols and final summary reports for validation/qualification activities.
· Write and review documentation as required for validation activities including risk assessments, mitigation strategies, and investigations of nonconformances.
· Initiate and assist in Investigation of QIRs and corrections in cooperation with QCM, as related to validation activities.
· Ability to handle multiple projects and work independently.
· Support FAT/SAT activities at vendor facilities as required.
· Perform training and retraining for QC and Production employees, as required
· Preparation, editing and publishing of quality documents according to valid QMI if assigned
· Other duties as assigned.
· Cooperation with external suppliers and other companies are required.
· Quality representative in validation and qualification activities.
· Organize and perform special testing in cooperation with QCM, as related to validation activities.
· Edit, update, and maintain relevant procedures for quality department according to quality guidelines.
· Communication and information exchange with affiliated Greiner facilities.
· Write and review validation documentation.
· Bachelor’s degree in Science, Chemistry, Engineering or a related field is required.
· Must have at least 3 years of experience in the medical device or pharmaceutical manufacturing environment (ISO 13485 preferred).
· Demonstrated experience and knowledge of qualifying changes to validated systems, processes, and equipment.
· Demonstrate strong understanding of 21 CFR 820 and ISO guidelines
· Ability to develop and execute process validation and equipment qualification protocols and reports.
· Ability to interpret engineering drawings.
· Proficient Computer skills and MS office skills including word processing, spreadsheet, and database software.
· Must have knowledge of basic statistics and calculations
· Must have good communication and writing skills.
· Must pass pre-employment examination and qualification test.
· Must be able to stand and walk for up to 8 - 12 hours.
· Must be able to lift up to 50 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.
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