What are the responsibilities and job description for the Quality Assurance Specialist position at Amerit Consulting?
Position: Quality Assurance Specialist
Location: Lexington MA 02421
Duration: 6-month contract with possible extension
Pay Rate: b/w $32/hr - $34/hr (depending on experience)
Relocation Expenses/ Assistance: NO
Job Description:
A detail-oriented Quality Assurance Specialist with a strong background in documentation review, inventory management systems (JDE or Oracle), and quality compliance in a regulated environment. The ideal candidate will be responsible for reviewing and releasing raw materials and batch records in a timely manner while supporting calibration, environmental monitoring, and preventive maintenance activities. This role also plays a key part in maintaining quality systems such as Audits, CAPA, and Management Review.
This position requires a high level of accuracy, strong communication skills, and the ability to handle multiple priorities efficiently. A strong sense of urgency and dedication to quality and compliance is essential.
Key Responsibilities:
- Independently review raw materials and subassemblies (yarns, fabrics, tubular fabrics) for conformance to specifications.
- Ensure all product lots meet required specifications and documentation before release.
- Maintain and organize lot history records, shipping authorization documents, and DHRs.
- Perform data analysis, documentation reviews, and maintain inspection/test records.
- Coordinate calibration schedules, maintain calibration logs, and assist in reviews.
- Support environmental monitoring reviews and documentation.
- Contribute to quality system functions including audits, CAPA, and management reviews.
- Assist in writing and updating inspection/test procedures.
- Maintain supplier quality databases and generate supplier history reports.
- Support the Quality Engineer with data input for procedures, protocols, and time studies.
- Ensure compliance with company rules, GMP, QSR, and all safety/quality standards.
- Perform other related duties as assigned.
Job Requirements:
- Associate degree in Sciences or related discipline, OR High School diploma with minimum 4 years of relevant quality experience.
- 2 years of experience in a medical device or other regulated industry.
- Experience with inventory management software such as JDE or Oracle.
- Familiarity with calibration processes and environmental monitoring.
- Prior experience in documentation review, data analysis, and QA records management.
- Experience supporting CAPA, audits, and supplier quality activities.
- Strong attention to detail and ability to follow written specifications accurately.
- Ability to manage multiple priorities in a fast-paced environment.
- Proficient in Microsoft Office (Excel, Word) and basic statistical tools.
- Strong written and verbal communication skills.
- Team player with a collaborative mindset.
- Basic knowledge of GMP and Quality System Regulations (QSR).
Salary : $32 - $34
