Senior Microbiology Analyst

Senior Microbiologist

The Senior Microbiologist is a critical technical resource in the QC Microbiology laboratory supporting the manufacturing of sterile injectable products. This position is responsible for independently performing and overseeing complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA, and internal quality standards. This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry.

This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological testing. Maintains spreadsheets and databases to track and monitor department/company data, KPIs and metrics. Accountable for QC Microbiology inventory control including ordering materials, maintaining stock and resolving material complaints as needed. This role will serve as a Subject Matter Expert (SME) to provide guidance and support junior microbiologists. Train team members in aseptic technique, microbiological methods, EM sampling, and good documentation practices. Participate in the qualification of microbiology lab equipment. Identify and implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory.

Operational Excellence:

• Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.
• Communicate progress, status, and roadblocks as required.
• Drive projects, assignments, and complete presentations within timelines and budgets. Create and maintain relevant metrics for department/site.
• Spreadsheets and databases will be leveraged for departmental and company metrics, presentations, and data/testing tracking/verification. The Senior Microbiologist is responsible for keeping these sheets and databases up to date.
• Ability to perform routine testing of samples submitted to the laboratory as appropriate. Schedules and participates in cleaning, inventory, and maintenance tasks in the lab.
• Supports inventory management and ordering/stocking of all QC department laboratory supplies.
• Ensures laboratory equipment is in compliance with procedures and GLP requirements.
• Troubleshoots laboratory issues related to all instrumentation. Recommends potential corrective and/or preventive actions and implements these actions within the laboratory.
• Performs GMP review of test data to ensure that test results meet all specifications. Trends data and analyzes trends to proactively mitigate equipment and reagent performance issues. Verifies laboratory equipment and associated equipment logs to ensure proper operation

Stakeholder:

• Preparation, review and approval of sampling matrix and hold time schedule Conducts and communicates results of lab investigations when test results fall outside pre-established specifications (OOS).
• Performs routine equipment maintenance.
• Performs maintenance of spare parts inventory, calibrations and supervises third party maintenance and repair when necessary.
• Establishes good working relation with contract laboratories.
• Supports in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ/PQ protocols.
• Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
• Conducts statistical evaluation of the manufacturing and inspection process and training QC staff.
• Ensure that all equipment is calibrated.
• Responsible to develop and validate new test procedures
• Perform data analysis, compile data and generate reports for management review.
• Review lab test data and their integrity and adherence to SOPs and cGMP.

Compliance:

• Maintain current knowledge of regulatory and industry standards, trends and advancements.
• Responsible for ensuring compliance to systems and procedures in the EM/Microbiology laboratory and cleanroom areas. And prepare the lab for internal and external audits.
• Support Continuous Improvement initiatives by providing support on updating SOPs, WIs, and OJT
• Complete and maintain certified investigator training requirements. Perform investigation of the quality events assigned using root cause analysis tools, maintain timelines for closure of investigations and identify/initiate CAPAs
• Complete and maintain status as a certified trainer
• Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures
• Evaluates and assists in the implementation of new changes at the site, including providing training on an as needed basis
• Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation.
• Performs regular self-audits of the Microbiology and EM laboratory areas (including storage areas) and assists/leads activities to address audit findings.

Stakeholder:

• Works collaboratively with other department stakeholders to ensure the services provided to the site are developed, tested, and delivered according to established procedures and regulations.

Innovation:

• Supports purchasing QC EM laboratory supplies. Makes sound, well considered decisions to make the most of available funds and resources. Monitors lab supply costs and looks for ways to work with suppliers to reduce consumables cost when appropriate.
• Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly. Makes realistic and actionable plans to address supply chain issues.
• Maintains the QC department ordering system to reduce costs and waste due to expiry. Keeps current on physical and computerized tracking systems for materials and supplies.

Safety:

• Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties

Knowledge, Skills and Abilities:

Education:

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology

Experience:

• Minimum of 3+ years in a pharmaceutical environment
• Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently.
• Excellent written communication and technical writing skills. Clearly demonstrates competence in the selection and use of root cause analysis tools and techniques (e.g., 5 Whys, Pareto Analysis, 5M +E).
• Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing Microbiology/EM laboratory tasks.
• Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).
• Displays ability to achieve Glenmark Monroe QE investigator certifications for product/process/testing/facility issues with product and non-product impact.
• Exhibits both analytical and problem-solving skills. Proven ability to problem solve/troubleshoot and provide solutions for laboratory issues.
• Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system.
• The ability to work independently and within team structure and on multiple projects, with flexibility to adapt to changing priorities is required. This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills.

Ability to lift 30 lbs.' and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions.