QA Document Control Specialist

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