We are seeking a highly motivated individual to join us as a Specialist in the QC Microbiology Laboratory, supporting the Newark Quality Control Organization. In this role you will support, perform and / or coordinate standard microbiology tests as well as environmental monitoring for clinical and commercial manufacturing of final drug product in a GMP work environment. The selected individual will be responsible for environmental monitoring programs, raw material testing, in-process and final product testing. Candidates must be well versed and be able to execute various microbiological techniques including rapid microbiology test methods, and qualifying microbiological methods for product and raw materials testing with reference to cell therapy products.
Responsibilities include, but are not limited to:
- Support the implementation of product and raw materials microbiology testing program (Sterility and Bacterial Endotoxins)
- Work with internal and external resources to maintain the laboratory in an optimal and compliant state.
- Support the qualification and validation of microbiological methods.
- Generate, revise, and review SOPs, qualification/validation protocols and reports.
- Assist in investigations regarding out of specifications (OOS) results. Address and manage deviations related to micro processes and / or procedures. Provide updates at daily and weekly meetings.
- Monitor the GMP systems currently in place to ensure compliance with documented policies.
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Coach and train other analysts to qualified level.
- Contribute to continuous improvement opportunities for methods optimization, coordinating re-validation, and drafting SOPs, where necessary.
- Troubleshoot methods and analytical instrumentation; improves existing methods to optimize efficiency wherever possible.
- Establish/maintain and minimize workload, streamlining existing systems and ensuring adherence to all appropriate internal and external guidance.
- Lead method validation and transfer activities for the QC Microbiology group and support instrument qualification activities. Serve as point person for the group.
- Maintain close interaction and communication with various cross-functional groups within and outside of the Quality Control Microbiology organization to ensure on-time and dependable related decisions.
- Interact with regulatory agencies, customers, and internal auditors/inspectors.
- Represent QC Microbiology at operational and cross-functional meetings; prepares and presents information; provides decision making support at meetings and disseminates information back QC Micro Lab.
- Participate in Technology Transfers, New products introductions, microbiology methods qualifications and method validations, as required.
- Interact with Inspectors from Regulatory agencies and participate in Pre-Approval Inspections.
- Gather metrics information for use in continuous improvement of areas of responsibility.
- Perform other duties within QC, as required.
Position Requirements & Experience:
- Bachelors Degree (BS) in Microbiology (preferred) with 8+ years of QC Microbiology Lab experience or Masters in Science (MS) with 6+ years of QC Microbiology lab experience, or Ph.D. and 3 years of experience.
- Experience in the biotechnology and/or pharmaceutical industry
- Must have experience with Quality Systems such as Laboratory Investigations, Deviations, Full Investigations, CAPA, Change Control and Risk Assessments Tools.
- Experience authoring SOPs, protocols, and technical reports to support operations within QC Microbiology Laboratories.
- Experience in Sterility tests and Bacterial Endotoxins testing is a plus.
- Working knowledge in regulatory requirements (21 CRF Part 11/210/211) and aseptic processing manufacturing.
- Strong knowledge of cGMP, SOPs and quality control processes.
- Proficient in MS Word, Excel, Power Point, and other applications.
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- Experience in leadership is highly desirable.
- Candidates must be authorized to work in the U.S.