Quality Assurance Specialist II

Job Title:

Quality Assurance Specialist II


·   Support the administrative Irregularity Report process for customer complaints and purchased product

·   Assist in evaluation of customer returned product (technical and administrative claims, customer returns), according to valid procedures

·   Lead evaluation and investigation on Bioscience product complaints with local QA/QC Manager

·   Initiate and assist in root cause analysis and investigation for quality relevant QIRs and CAPAs

·   Provide support during the planning and development of validation strategy

·   Provide support and monitoring of activities during validations, material trials, and special projects

·   Review and edit quality relevant processes and procedures to optimize and improve.

·   Perform training and retraining for QC and Production employees, as required

·   Support maintenance of records for validation, material trials, and projects.

·   Mentor, coach and train to establish quality assurance and validation competencies.

·   Support SAP Key User functions in QM

·   Other duties as assigned.



·   Communication with headquarters, corporate suppliers and local suppliers regarding Irregularity Reports

·   Evaluation of complaint responses, and formulation of complaint statements

·   Evaluation of product according to valid QMI documents.

·   Review and Approval of QA/QC documentation relevant to responsibilities

·   Support the quality representative in validation and qualification activies

·   Quality representative in CAPA and root cause investigation

·   Training of QC and Production personnel regarding procedures and use of equipment

Job Requirements:


·   Minimum high school diploma; Associates degree preferred

·   At least 3 years of experience in 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.

·   Experience supervising and/or leading employees is preferred.

Physical Requirements:

·   Must be able to stand and walk for up to 8/12 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.3


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