Summary:

Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.

Functions:

1. Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
2. Resolve technical issues and troubleshoot for assays as necessary, ensure lab compliance which includes implementing procedures that enhance GMP, GLP and safety.
3. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
4. Approve lab investigations, lead audit teams.
5. May serve as subject matter expert to develop technical training.
6. May perform routine work in a specific area of responsibility as necessary.
7. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
8.  May interact with regulatory agencies regarding area(s) of responsibility including written responses.
9. May resolve issues with outside resources.
10. Performs special projects as requested by supervisor, may supervise employees as necessary to meet technical requirements.

Education Requirements:

• Doctorate degree or Master's degree and 3 years of directly related experience.
• Bachelor's degree and 5 years of directly related experience.
• Associate's degree and 10 years of directly related experience.
• High school diploma / GED and 12 years of directly related experience.

Preferred Qualifications:

1. Knowledge on Laboratory Analytical Assets.
2. GMP Documentation
3. Computerized Maintenance ( Asset / PM creation, Documentation, etc.).
4. Good Written and Communication Skills.

Work Methodology:

• 100% On-site 
• Full Time Opportunity
• Administrative Shift (weekends and overtime may also be required).
• 6 months of 1st contract.
• Professional Services