Job Description
Job Description
Quality Assurance Associate – Manufacturing
Job Type: Full Time Monday - Thursday 2pm to 1am
Overtime: Hours worked over 40 per week paid at Time and a Half
Education: High School Diploma or GED Required
Experience: 1–3 Years
Job Summary
We are seeking a Quality Assurance Associate – Manufacturing to support product quality and manufacturing processes within a regulated Good Manufacturing Practices (GMP) environment. This is an entry-level individual contributor position and a common entry point into the Quality Assurance career path.
Working under direct supervision, the Quality Assurance Associate will assist with Device History Record (DHR) review, manufacturing quality issues, product disposition, documentation practices, and production systems. This position will also help ensure manufactured products meet applicable product specifications and established quality requirements.
Key Responsibilities
- Review Device History Records (DHRs) in both paper and electronic formats for completeness and accuracy.
- Assist with quality issues identified on the manufacturing floor and support appropriate follow-up activities.
- Assist with product disposition activities in accordance with established procedures and quality requirements.
- Maintain a strong understanding of Good Documentation Practices (GDP) and apply documentation requirements consistently.
- Utilize and navigate manufacturing and production systems, including MES, SAP, and Windchill.
- Assist in verifying that manufactured products align with applicable product specifications and established quality requirements.
- Support manufacturing personnel with quality-related questions and issues under the direction of Quality leadership.
- Review manufacturing documentation for accuracy, completeness, and compliance with applicable procedures.
- Follow established GMP procedures, SOPs, work instructions, and quality processes.
- Communicate quality concerns and documentation discrepancies to the appropriate personnel.
- Maintain accurate records and documentation while working within a regulated manufacturing environment.
- Support the overall quality of manufacturing operations while following established safety and compliance requirements.
Qualifications
- High School Diploma or GED required.
- 1–3 years of relevant experience in quality, manufacturing, production, medical device, pharmaceutical, or another regulated environment.
- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Experience or familiarity with manufacturing documentation and production processes.
- Ability to review detailed records and identify missing, inaccurate, or inconsistent information.
- Familiarity with production/manufacturing systems such as MES, SAP, or Windchill is preferred.
- Strong attention to detail and ability to maintain accurate documentation.
- Ability to follow established procedures and work instructions under direct supervision.
- Effective written and verbal communication skills.
- Ability to work collaboratively with Manufacturing, Quality, and other cross-functional teams.
Quality & Manufacturing Environment
This position works directly within a GMP-regulated manufacturing environment and requires careful attention to documentation, product specifications, manufacturing processes, and quality requirements. The successful candidate will be expected to consistently follow established procedures and maintain accurate records.
Keywords
Quality Assurance • Quality Associate • Quality Assurance Associate • Manufacturing Quality • Quality Control • GMP • Good Manufacturing Practices • GDP • Good Documentation Practices • DHR • Device History Records • DHR Review • Product Disposition • Quality Issues • Manufacturing Quality Issues • Medical Device Manufacturing • Regulated Manufacturing • MES • SAP • Windchill • Production Systems • Manufacturing Documentation • Product Specifications • SOPs • Work Instructions • Documentation Review • Quality Compliance