QA Document Control Specialist job in Philadelphia, USA

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)

Location: United States

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

Proclinical is seeking a QA Document Control Specialist to join a cutting-edge biotech company located in Philadelphia, PA.

Must be eligible to work in the US.

Job Responsibilities:

Independently manage and monitor the processing, review, and approval of revision- controlled documents in the Electronic Document Management System (eDMS).
Provide user assistance and training on the eDMS.
Ensure compliance with controlled document format and content.
Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized.
Manage the document periodic review process.
Issuance of batch records, forms, logbooks, validation documents, labels, and other controlled documents as required.
Provides support for internal and regulatory audits and inspections as required.
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

Skills and Requirements:

Bachelor's degree in Life Sciences discipline
Two (2) years of demonstrating MS Office Suite and Archival skills
Proficient in an eDMS system and document formatting
MasterControl or Veeva Vault experience
Must possess a high level of attention to detail and proficient in Word and Excel.
Strong computer, organizational, and compliance skills
Familiarity with document change management and FDA quality systems
Ability to work effectively on multiple projects simultaneously with minimum supervision.
Strong interpersonal and communication skills

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215-531-6914 or s.briggs@proclinical.com.

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.

INDCQA