Responsibilities
- Carry out standard and moderately complex microbiological testing to support quality control functions and contribute to operational processes, working across departments during early site setup phases to define user needs and prioritize equipment, instrumentation, method implementation, and digital quality systems such as LIMS, ELN, and LES.
- Conduct and support qualification and transfer of pharmacopeial and non-routine microbiological methods following GxP, SOPs, and specifications, using techniques like bioburden testing (TAMC/TYMC), bacterial endotoxin detection (LAL), growth promotion, microbial identification, and rapid microbiological methods.
- Apply practical understanding of sampling, culturing, microscopy, and aseptic practices across diverse sample types including water, air, gases, raw materials, surfaces, in-process samples, drug substance, stability samples, and investigations.
- Support the creation and upkeep of site-specific quality control procedures within the global Veeva electronic Quality Management System (QMS) to ensure the microbiology lab is operationally ready.
- Engage in site-level risk management initiatives, recording risk-based decisions using compliant methodologies and supporting data, and work with colleagues to integrate risk principles into daily QC workflows.
- Execute GxP-aligned procedures for Environmental and Utility Monitoring Programs and Contamination Control Strategies in coordination with cross-functional teams.
- Train and qualify personnel in microbiological techniques and contamination control practices, and assist in onboarding junior team members and contractors according to approved staffing plans.
- Support utility system qualification and environmental monitoring performance qualification (EMPQ) to ensure facilities meet production timelines and readiness requirements.
- Review validation and qualification documents for facility systems, microbiological instruments, and computerized systems to verify commissioning and operational preparedness.
- Coordinate and carry out sampling and testing activities, and review QC lab results for accuracy and completeness under moderate supervision.
- Maintain essential laboratory operations including gowning procedures, personnel and material movement, sample handling, inventory control, lab safety, waste disposal, and cleaning protocols.
- Prepare and contribute to laboratory documentation such as microbial trend summaries, environmental and utility monitoring recovery reports, excursion reports, out-of-specification (OOS) investigations, and invalid assay records.
- Work with Operations, Quality Assurance, and Compliance teams to align microbiology QC activities with global and regional policies and inspection preparedness expectations.
- Participate in investigations of non-conformances, deviations, and lab exceptions, and assist in writing and executing corrective and preventive actions (CAPAs).
- Monitor and report key performance indicators (KPIs) for site quality metrics, including deviations, CAPAs, change controls, OOS results, invalid assays, out-of-trend (OOT) events, equipment failures, environmental monitoring trends, stability data, and product disposition cycle times.
- Take responsibility for assigned tasks and provide technical input to build a compliant, science-based QC Microbiology function aligned with organizational manufacturing and quality objectives.
- Track progress toward individual and team goals and communicate updates to the Site Leadership Team and relevant stakeholders.
Team
Reports to Senior Manager, Quality Control
Team
Reports to: Senior Manager, Quality Control
Other
- As an individual contributor, you will take a compassionate and people-focused approach to your work.
- You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values.
- You will be accountable for delivering results, adapting to challenges, and helping achieve business goals.
- You will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow.
- You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.
