Documentation Specialist (Pharmaceutical/Biotech)
Job Description
- Independently manage and monitor the processing, review, and approval of revision- controlled documents in the Electronic Document Management System (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.
Required Education, Skills, And Knowledge
- Bachelor’s degree in Life Sciences discipline
- 1-2+ years demonstrating MS Office Suite and Archival skills
- Proficient in an eDMS system and document formatting
- Must possess a high level of attention to detail and proficient in Word and Excel.
- Familiarity with document change management and FDA quality systems
Company Description
R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.
The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
R&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL. The cornerstone of our success: a knowledgeable and experienced recruiting team. Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
