Quality Engineer

We are reputed staffing agency, founded in 1999, Mindlance is a certified diversity business (MBE) and has been ranked one of the fastest growing U.S staffing firms by SIA for eight consecutive years. Title: Quality Engineer Duration: 18 months Location: Rocky Mount, NC Job Description: The Annual Product Record Review Associate is responsible for writing Annual Product Record Review (APRR) reports according to pre-approved calendar, company procedures and our Quality Agreements. The job duties include, but are not limited, to the following: - Establish the product matrix and the APRR calendar - Gather the required data and write APRR reports according to the calendar - Analyze trends, make recommendations based on the data in order to improve processes or tools - Send approved reports to clients according to applicable Quality Agreements - Must be able to work and communicate effectively with all levels of people within the other Client sites - Must be able to work and communicate effectively with all levels of people within the Client organization. - Must be able to work and communicate effectively with all types of suppliers to help resolve issues   Education Bachelors Degree with 2+ years working in a GMP FDA regulated environment Minimum of 1 years of experience in one or more of the following: - Quality Engineering/Compliance/Regulatory Affairs - Manufacturing/Technical experience in Pharmaceutical or GxP regulated environment Technical Skills - Strong analytical skills and ability to summaries vast amounts of data - Capacity to manage several projects at a time - Knowledge of the local & international regulatory requirements and Quality Management standards & systems - Strong organizational, presentation, meeting facilitation and technical writing skills. - Possess attention to detail and good communication skills as verbal and written feedback to departments is required when issues are discovered during auditing. - Strong computer proficiency skills in MS Office, Word, Excel, Project, Trackwise (ER / LIR), and Empower LIMS System or equivalent. - ASQ Certification preferred. Physical Position Requirements - Ability to work extended hours, especially during health authority inspections, assessments and audits. - Allow for flexibility in shifts to accommodate ad-hoc assignments on an as needed basis   All your information will be kept confidential according to EEO guidelines.