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Microbiology - Environmental Monitoring (EM) Team Lead

Department: Microbiology

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No Visa Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

POSITION SUMMARY:

The QC Microbiology/EM Team Lead provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring (EM), including applicable support and storage areas, to ensure manufactured products are appropriately measured and monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (e.g., FDA 21 CFR, USP, EU Annex-1).

This position is in a fast-paced, FDA regulated environment in the Pharmaceutical Industry. QC Microbiology/EM Team Lead is a key position with expected knowledge and comprehension of subject matter related to EM and microbiological laboratory testing related to sampling and analysis of Utilities (e.g., Compressed gases, Water for Injection, Purified Water, Pure Steam). They are responsible for ensuring microbiological and EM testing is performed in compliance with procedures and GDP requirements including growth performance, antimicrobial neutralization and contamination checks, bioburden and environmental monitoring sampling/testing of water, surface, air, and cleaning. This position requires a 100% on site presence.

Operational Excellence :

+ Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.

+ Monitors and communicates progress of team through KPI (Key performance indicators), which align with company and site objectives.

+ Drive projects, assignments, and complete presentations within timelines and budgets.

+ Spreadsheets and databases will be leveraged for departmental data/testing tracking/verification. The QC EM Team Lead is involved in making key decisions for the Microbiology and EM laboratories, projects, and resource allocation/scheduling.

+ Motivates and inspires colleagues to achieve top performance, growth, and development within the team

+ Ability to perform routine testing of samples submitted to the laboratory as appropriate.

+ Accountable for inventory management and ordering/stocking of all QC department laboratory supplies.

+ Ensures laboratory equipment is in compliance with procedures and GLP requirements. The QC EM Team Lead is responsible for making sure all laboratory instrumentation is appropriately validated, calibrated, and monitored for compliance. Troubleshoots laboratory issues related to all EM instrumentation.

+ 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.

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 OJTs

+ Perform investigation of the quality events assigned using root cause analysis tools, maintain timelines for closure of investigations and identify/initiate CAPAs

+ Evaluates and assists in the implementation of new changes at the site

+ Provide support to reconcile and prepare EMPQ reports, EM Trend reports, and QMR board presentations with associated documentation.

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.

+ 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:

+ Ensures the team complies with all safety policies and procedures at all times.

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

Education:

Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology or equivalent

Experience:

Minimum of 4+ years

Knowledge and Skills :

+ 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.

+ Demonstrates proficiency in human resource management for the efficient and effective management of direct reports and team development.

+ Able to assess safety and environmental risks to ensure laboratory tasks adhere to EHS management system.

Leadership / Managerial Attributes:

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.

Other requirements :

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

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