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

Qualifications

BASIC MINIMUM QUALIFICATIONS :

• Bachelor’s degree
• 8+ years of experience in a GMP environment
• 2+ years in a project leadership experience
• Advanced knowledge in microbiology and / or in EM / UM, and GMP
• Experience setting up a new laboratory

PREFERRED QUALIFICATIONS :

• Master’s degree
• Ability to formulate solutions adoptions for team and reach out externally to regulatory / global teams / sites for alignment.
• Must be able to assist in setting and reporting measurable goals & targets and mitigation plans as appropriate microbial methods or EM and UM.
• Demonstrated leadership abilities, strong presentation, oral and written communication skills; ability to communicate with management, peers and subordinates effectively, strong organizational skills;

ability to multi task and coordinate multiple activities in parallel, demonstrated problem solving skills, demonstrated instrument / method troubleshooting skills, understanding of relevant FDA / EMA regulations and compliance.

• Broad knowledge of operations / quality systems / directives, Accountability for self and immediate work team through delivery of appointed deliverables.
• Excellent technical writing skills; authors technically sound simple to moderately complex reports with limited guidance.
• Leadership competencies include Follow up, Decision Making, Communication, Collaboration and Innovation
• Able to work effectively, independently and within a team framework, across all business areas and levels of the organization

Additional Information

Position is Full Time, Monday-Friday, First Shift. Candidates currently living within a commutable distance of H olly Springs, NC are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.