QC Laboratory Supervisor (Microbiology)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

1. Design and Start-up Micro Lab on site.
2. Supervise and coordinate resources to support routine and non-routine sample testing.
3. Effectively recruit the right people to support the laboratories activities and ensure that human resources are optimally utilized.
4. Ensure lab spending is appropriate and within planned budgets.
5. Ensure all testing is carried out in a timely and efficient manner to meet release lead time and site metrics and release of laboratory test results.
6. Review and approve any method transfer or method qualification reports or equipment qualifications.
7. Provide oversight on lab equipment calibration and maintenance program.
8. Investigate and/or provide guidance to resolve any deviation observed during lab testing or any other lab operations, and ensure all CAPAs are implemented effectively.
9. Develop and maintain environmental monitoring program and microbiological laboratory procedures.
10. Lead validation of equipment and test methods for purified water.
11. Lead test method transfer of microbiological method.
12. Train laboratory team in operational tests and sampling methods.
13. Participate and support audit preparation and audit responses, including the development and implementation of programs to provide timely follow up on corrective actions and commitments.
14. Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Support CI initiatives and laboratory performance metrics.
15. Provide technical support to laboratory personnel and provide guidance and training to all analysts to upgrade their technical competencies.
16. Any other tasks as and when assigned by Supervisors.

Qualifications

1. Bachelor of Science majoring in Microbiology or related scientific degree.
2. Minimum 8 years of pharmaceutical experience in an analytical testing environment within Quality department and with good knowledge of aseptic process manipulation together with experience within a GMP environment and knowledge of current EU/FDA/ICH/IMB guidelines.
3. Minimum 3 years of supervisory experience in Biotechnology/Pharmaceutical Manufacturing area.
4. Strong analytical mind with good problem solving and writing skills.
5. Highly motivated and independent.
6. Possess strong interpersonal and communication skills, with ability to work within cross-functional teams.
7. Organized and result-oriented.
8. Ability to work under tremendous pressure.
9. Approachable with good leadership qualities.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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