Position SummaryThe Senior Analyst, QC Microbiology performs and documents microbiological testing on raw materials, in-process and finished products, and environmental samples. The role ensures GMP compliance through timely review of laboratory data and documentation, communicates findings, and supports corrections. This position also authors SOPs and serves as a subject matter expert for the EDMS system.
Position Responsibilities- Evaluates data trends and authors reports associated with trends.
- Leads and/or actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing.
- Provides and follows up on ideas for continuous improvements in laboratory processes.
- Maintains and troubleshoots testing equipment.
- Completes required training and trains QC employees in GMP, SHE, QC methods and processes. As well as, good aseptic techniques, and instrumentation based on expertise.
- Actively support and/or lead the implementation of compendial changes for raw materials, in-process or finished products tests in accordance with applicable Pharmacopoeias such as USP/NF, European Pharmacopeia, British, and Japanese Pharmacopeia.
- Troubleshoots methods and processes.
- May serve as an expert in a specific area of laboratory equipment, process, or system.
- Serve as a subject manner expert during regulatory inspections including potential demonstrations and inspection room discussions.
- Demonstrates expertise on authoring Quality records (Deviations, CAPAs, and Change Controls).
- Answer and guide others in documentation, compliance, and other process questions.
- Gather, organize, and communicate operational information to others.
- Facilitate communication between management and non-management and team meetings.
- Provide leadership, development, and mentoring for others.
- Provide support in coordinating activities in the laboratory.
- Identify temporary and permanent fixes to address issues.
- Coordinate with representatives from other departments.
- Attend team meetings to discuss progress, initiatives, and/or other matters.
- Collect, record, report and trend metrics when applicable.
- Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
- Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
- Perform logbook reviews.
- Lead process improvement activities and teams to meet strategic goals.
- Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
- Alert supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures).
- Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
- Review and approve documentation needed for qualification of equipment and processes.
- Attend and facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments when necessary.
- Interact with other departments to implement corrective/preventative actions.
- Review and approve quality records as a SME when required.
- Provide "off shift" support (i.e., night shift support if you normally workday shift).
- Coordinate qualification activities.
- Assess and implement improvements in productivity, waste generation, quality and cost.
- Recommend compliance resolutions to management.
Hours (Day Shift):- Sunday - Wednesday
- 10 hour shift
Minimum Qualifications- Prior experience in a regulated GMP environment.
- Working knowledge of cGXP requirements and a strong familiarity with production operations.
- Excellent attention to details and problem-solving skills.
Preferred Qualifications- Bachelor's degree in a Science subject (Microbiology, or closely related subjects)
- 5 years QC Microbiology laboratory experience.
- High level knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.
- Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.
This position may also include the following conditions:
- This role is primarily non-sedentary. May include but not limited to standing, walking, repetitive motion, and chemical usage.
- All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
- The items described here are representative of those that must be met successfully to perform the essential functions of this job.
- The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.
Sponsorship or support for work authorization, including visas, is not available for this position. 
