Glenmark Pharmaceuticals · 2 hours ago
Senior Microbiology Analyst
Monroe, NC
Full-time
Onsite
Mid, Senior Level
3+ years expGlenmark Pharmaceuticals is a company focused on the pharmaceutical industry, and they are seeking a Senior Microbiology Analyst to support the manufacturing of sterile injectable products. This role involves overseeing microbiological testing, maintaining compliance with quality standards, and providing guidance to junior microbiologists.
BiotechnologyHealth CarePharmaceutical
No H1B
Hiring Manager
Gayathri Kirthivasan
Responsibilities
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
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
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
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
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
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
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
Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties
Qualification
Required
Applicants must be authorized to work for ANY employer in the U.S
Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology
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
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
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