Johnson Service Group (JSG) are currently looking for
a General Administrator in Validation. This is a
6 month to 1 year contracting opportunity with a world leading pharmaceutical company located in
Albany, NY.Hourly rate $35.00 to $40.00Overview: We are seeking a detail-oriented and proactive Validation General Administrator to support the QA Validation Cleaning Group. This position plays a critical role in managing Good Documentation Practices (GDP) documentation, facilitating cross-department communication, and ensuring compliance with GDP and GMP standards. The successful candidate will have strong organizational skills, experience with validation processes, and the ability to collaborate across teams.
Key Responsibilities:
- Documentation Management:
- Transport and manage GDP documentation between client sites and secure necessary manufacturing department signatures.
- Perform extensive reviews of documentation for GDP and GMP compliance, ensuring accuracy and adherence to regulations.
- Archive and reconcile validation documents in compliance with established protocols.
- Communicate and interact with various team members within the validation team to understand and deliver documents effectively.
- Assist the administrative subgroup in executing additional tasks beyond the typical scope, contributing to the overall success of the team.
- Coordinate with manufacturing personnel to gain approvals on QA cleaning validation protocols.
- Protocol Preparation and Review:
- Assist in ordering and preparing QA cleaning validation protocols for execution.
- Generate, implement, and review master and completed qualification and validation protocols, summary reports, and associated data.
- Analyze testing results to determine their acceptability based on predetermined criteria.
- Problem-Solving and Compliance:
- Investigate and troubleshoot issues, providing recommendations for improvements or changes.
- Review, edit, and approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, and other critical documents.
- Utilize software and database management tools such as Veeva, MS Office Suite, Blue Mountain Regulatory Asset Manager, LIMS, and SharePoint to manage and track documentation and validation activities.
Qualifications:
- Familiarity with GDP, GMP, and validation processes within a pharmaceutical or biotech environment.
- Experience with database management systems and software such as Veeva, LIMS, and SharePoint.
- Strong organizational and multitasking skills with attention to detail.
- Excellent communication and collaboration skills, with the ability to work across multiple teams and departments.
- Proven ability to manage documentation workflows and ensure compliance with regulatory standards.
Preferred Experience:
- Previous experience in validation administration or a similar role in the pharmaceutical industry.
- Knowledge of QA cleaning validation processes.
- Experience reviewing and managing deviation notifications, corrective actions, and change controls.
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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