Job Title: Quality Assurance Associate

Job Description

Ensure compliance with Quality System requirements, cGMP, FDA, and ISO standards. Responsibilities include receipt and review of documents such as charts, logs, batch records, and approval of incoming materials for release. Provide floor support to production departments, including line clearances, in-process checks, and assistance with investigations. Review and approve supplemental logs, charts, and other documents in support of cGMP operations. Review batch records for accuracy and completion prior to final release of the product. Perform product releases specifically for fills and intermediate lots. Coordinate product releases with distributors and customers as needed. Provide quality assurance support for investigations, including nonconformance and root cause analysis. Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned. Issue, review, and reconcile batch records as needed.

Hard Skills

• Quality System requirements
• cGMP
• FDA standards
• ISO standards
• Investigation
• Root Cause Analysis

Job Type

This is a Contract-to-Hire position with a duration of 6 Month(s).

Work Site

This is a fully on-site position in Bedford, Massachusetts.

Work Environment

Work in the quality department with 4 other team members. Work 1st shift M-F. Collaborative and team-oriented group with a business casual dress code.

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $25 - $30