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Actalent QA Compliance Specialist in Bedford, Massachusetts

Job Title: QA Compliance SpecialistJob Description

As a QA Compliance Specialist, you will be responsible for ensuring compliance with Quality System requirements, cGMP, FDA, and ISO standards. Your key responsibilities will include the receipt and review of documents such as charts, logs, and batch records, as well as approving incoming materials for release. You will provide critical floor support to production departments, assisting with line clearances, in-process checks, and investigations. Additionally, you will review and approve supplemental logs and documents supporting cGMP operations, ensure the accuracy and completion of batch records before the final product release, and perform product releases for fills and intermediates. Coordination with distributors and customers for product releases and providing quality assurance support for investigations, including nonconformance and root cause analysis, are also integral parts of this role. You will perform quarterly walkthrough audits of manufacturing and packaging areas and complete assigned audit activities.

Hard Skills

  • Quality System Compliance

  • Investigation

  • Root Cause Analysis

  • Batch Record Management

  • cGMP Operations

Soft Skills

  • Team Collaboration

  • Attention to Detail

  • Problem Solving

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

The role is positioned within a collaborative and team-oriented quality department consisting of 4 other members. You will be working under the guidance of the director of quality, Plecille. The standard working hours are Monday to Friday on the 1st shift. The dress code is business casual.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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