Quality Engineer

Company Description 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.

Job Description

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

Qualifications

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

Additional Information All your information will be kept confidential according to EEO guidelines.