Qc Microbiologist (Sme) - Biopharmaceutical Site Start-Up

Job Description
POSITION SUMMARY:
We have an exciting opportunity for an SME in Microbiology to help our client set-up a new laboratory. The Principal Scientist, Microbiology is responsible for contributing to key functional, tactical, and operational aspects of the QC group at our client site.
This position will involve project management, initiation of process improvements, liaison for, qualification and validation activities, modeling the leadership competencies, aiding in the development of peers and performing QC approval, as required. This position is proficient in their understanding of Quality Systems and apply that knowledge in coaching and continuous improvements of systems cross‐functionally. at our PSS client site.
POSITION RESPONSIBILITIES:
Accountable for GMP compliant laboratory operations according to EU GMP and 21 CFR part 210, 211, 820, 11 and other applicable GMP guidelines
Mentors teams cross‐functionally as a representative of the QC Microbiology laboratory
Coordinates the review of analytical data to support test validation, qualification and certification activities.
Performs investigations, manages complex issues, barriers and problems to support team success. Approve data reports within the team and area of discipline/focus, including approval of results
Supports management for activities related to compliance with policies, providing feedback for personnel development, effective and timely decision making/corrective actions on the floor.
Actively provides leadership and mentoring as needed to aide in the development of the team
Authors protocols, change control requests, and Quality Technical Reports for ensuring successful execution of, qualification, analytical improvement projects, in collaboration with cross‐functional teams, as appropriate
Provides technical leadership through effective project management, status tracking, presentations, and communication.
Proactively identifies technical gaps and areas for improvement related to quality. Process and lead internal and external audits proficiently, including commitments on follow up, interfacing with key customers