Job Description

POSITION SUMMARY:

Working Hours for this position will be 1300-2200. Training will be completed during day shift (0800-1700 Monday-Friday). Once training has been completed, personnel will be released to the later shift, shift pass downs sent to management will be utilized.

The QC Microbiology Analyst I is responsible for performing routine microbiological sampling, testing and environmental monitoring in support of pharmaceutical manufacturing operations. This entry-level position plays a critical role in ensuring products meet regulatory and company quality standards by detecting and identifying microbial contaminants., 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 Analyst I is a key position with expected knowledge and comprehension of basic microbiology concepts and manufacturing practices. They are responsible for ensuring microbiological and EM sampling/testing is performed in compliance with procedures and GDP requirements. This position requires a 100% on site presence.

JOB RESPONSIBILITIES

Operational Excellence

• Models the principles and behaviors of Glenmark and ensures personnel follow the company code of conduct.
• Participate in projects, assignments, and complete presentations within timelines and budgets.
• Communicate progress, status, and roadblocks as required.
• Ability to perform routine sampling of utilities and EM monitoring.
• Train on routine testing of samples submitted to the laboratory.
• Participates in cleaning, inventory, and maintenance tasks in the lab.
• Accountable for inventory of QC department laboratory supplies.
• Ensures laboratory equipment is in compliance with procedures and GLP requirements prior to use.
• 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.

Compliance

• Train and perform on sampling of utilities.
• Train on microbial testing of routine microbiology samples of water systems (e.g., bioburden, endotoxin,).
• Conduct environmental monitoring of cleanrooms and controlled areas (viable and non-viable particulates, surface sampling, personnel monitoring).
• Prepare and maintain microbial cultures and media in accordance with laboratory procedures.
• Train on media qualifications, and microbial identifications.
• 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
• Ensure Quality Systems are compliant with cGMPs and internal/external regulations and procedures
• Assists in the implementation of new changes at the site,
• Provide support to collect and prepare EMPQ reports, EM Trend reports, QMR board presentations with associated documentation.
• Assist in regular self-audits of the Microbiology and EM laboratory areas (including storage areas). Assists inactivities 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

• Consults with management, when appropriate, about laboratory supply variances. Demonstrates the ability to assess upcoming laboratory supply needs and prepare accordingly.
• Demonstrates the ability to use available tools and technologies to track laboratory supply expenditures and usage. Coordinates efforts with suppliers to ensure inventory replenishment and avoid expiry.
• Analyzes laboratory supply usage patterns to anticipate upcoming needs.

Safety

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

KNOWLEDGE, SKILLS AND ABILITIES

Education

(degree / diploma)

Bachelor’s degree in Microbiology, Biology, or a related life science field preferred.

Experience

Minimum of 0-2 years

Knowledge and Skills (Functional / Technical)

• Understanding of aseptic technique and microbiological test methods.
• Strong organizational skills. Displays the ability to prioritize work and manage multiple tasks independently.
• Excellent written communication and technical writing skills.
• 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.
• Familiarity with regulatory guidelines (e.g., 21 CFR Part 11, USP <61>, <62>, <85>, <1116>).
• Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).
• 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.

Other requirements (licenses, certifications, specialized training)

• Ability to lift 30 lbs.’ and work within different extreme temperature / humidity environments as encountered in the various Incubator conditions.
• Must be able to work in cleanroom gowning and aseptic environments.

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