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Actalent QA Documentation Coordinator in MILFORD, Massachusetts

Description:

  1. Document control in FDA

  2. Data Entry

  3. GMP knowledge

Binding and scanning of documents for QA team

Manages document control systems and processes to ensure their integrity and compliance with cGMP regulations

Maintains master indices and tracking of standard operating procedures, deviations reports, change control reports, technical reports, protocols, batch record files, validation reports and non-conformance reports

Coordinates documentation activities to ensure that procedures are written, edited, reviewed and approved in a timely manner to meet established deadlines

Ensure that documentation/records are indexed, filed, archived, retrievable and issued, consistent with our clients procedures and policies

Assist in the development, approval, and issuance of quality system documents

Assist in updating procedures specific to the Documentation Department

Works closely with other departments to support their documentation activities  (This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections.)

Assist in continuous improvement initiatives

Strong attention to detail and self-checking skills

Skills:

quality assurance, Gmp, Document Control, Microsoft Office

Additional Skills & Qualifications:

The job requires a minimum of a high school diploma or equivalent and at least 1-3 years’ experience in documentation systems preferable in an FDA regulated industry.

Must have good organizational skills.

Solid skills with Microsoft Word, Access and Excel.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

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

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