Quality Engineer

Mindlance; Rocky Mount (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Mindlance is seeking a Quality Engineer in Rocky Mount, NC, for an 18-month position focused on writing Annual Product Record Review reports in compliance with regulatory requirements.

The role demands strong analytical skills and the ability to manage multiple projects effectively. Candidates should have a Bachelor's degree and experience in a regulated environment, alongside proficiency in tools like Trackwise and Empower LIMS.

Qualifications

• 2+ years in a GMP FDA regulated environment.
• Experience in Quality Engineering or Regulatory Affairs.
• Familiarity with Quality Management standards.

Responsibilities

• Write Annual Product Record Review reports according to schedules.
• Analyze data trends to improve processes.
• Communicate effectively with clients and suppliers.

Skills

Strong analytical skills

Knowledge of regulatory requirements

Strong organizational skills

Technical writing skills

Communication skills

Computer proficiency in MS Office

Education

Bachelors Degree in relevant field

Tools

Trackwise (ER / LIR)

Empower LIMS System

Job 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.