QA Documentation Specialist job in Frederick, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a QA Documentation Specialist with a pharmaceutical company located in Frederick, MD.

Job Responsibilities:

Provides clerical and administrative support related to documentation processes and systems.
Pre-approves and routes documents for review and approval in the electronic Document Management System (DMS).
Approves Document Change Controls and assigns effective dates to documents.
Pre-Releases documents for training and adds documents to curricula in the electronic Learning Management System.
Maintains the document archival room.
Print process labels for Manufacturing.
Responsible for filing and maintenance of all controlled documents and records. Ensures files are accurate and easily retrievable.
Creates logbooks to be used in production.
Scans, verifies and archives documentation and records as needed.
Performs general word processing tasks. Checks format and conformance to document templates. Ensure the correct and timely input of database entries.
Provides support to clients on the process of documents in the DMS.and word processing tasks as needed.
Participates in function meetings.
Notifies manager of compliance questions and issues.
Provides additional support and assistance on tasks and projects as directed by management.

Skills and Requirements:

Bachelor's degree or Equivalent Experience - Current Good Manufacturing Practices (cGMP) and Pharma Industry Experience

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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