The Company – Syner-G Pharma Consulting, LLC:
- A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls
(CMC) and Quality Assurance for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
- Clients include national and multinational pharmaceutical companies
Syner-G Pharma Consulting is seeking a talented QA Document Control Specialist with a BS/MS in science, chemistry, biology, or engineering. The Document Control Specialist will provide the support to document control program for Syner-G clients. The Document Control Specialist is responsible for preparing, reviewing, controlling, and managing documents from pre-clinical development through commercial. They will work on supporting daily document control operations through the process of filling records as well as maintenance of document control system and document archive room for the Syner-G Pharma clients. Additionally, they will also assist with reviewing and managing Syner-G internal documents.
Critical success factors:
- Business owner (point of contact) and subject matter expert for eDMS (Controlled Documents)
- Review and approve eDMS change control and validation documentation in cooperation with QS management
- Control documents and provide end user support and training for eDMS
- Provide records management support to Client Quality Operations
- Perform internal document and record audits.
- Manage periodic review process.
- Bachelor’s degree in life sciences or a technical discipline
- Minimum of 15 years’ experience required in working in QA document control management
- Knowledge of regulatory guidance’s and industry standards for QA document control area
- 15+ Years of Experience working with paper and EDMS (Electronic Document Management System)
- Experience in Preparing, reviewing, and editing cGMP batch records, CMC regulatory, and Quality documents.
- Experience writing/reviewing, and troubleshooting an EDMS
- Presents solid understanding of quality assurance concepts and practices
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Strong organizational, analytical, and problem-solving skills (e.g. tracking and managing multiple documents)
- Excellent written, verbal, and interpersonal skills
- Strong orientation for quality and customer services
- Able to work independently with moderate supervision, including ability to escalate appropriately