QA Document Control Specialist
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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.
- 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 firstname.lastname@example.org.
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.