Planet Pharma
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Job Title:
Analyst I, Quality Control Lab – Microbiology
Summary:
The Quality Control (QC) Microbiology Analyst is responsible for performing environmental monitoring, microbiological testing, and data analysis to support manufacturing operations in compliance with FDA, GLP, QSR, and cGMP regulations. This role ensures product quality, maintains data integrity, and contributes to continuous improvement initiatives within the QC laboratory.
Key Responsibilities:
Perform environmental monitoring in ISO 5, 7, 8, and 9 cleanrooms and collect water samples.
Conduct microbiological testing on raw materials, in-process, and finished product samples.
Support assays such as endotoxin testing, bioburden analysis, and growth promotion.
Read and interpret microbial plates and record test results accurately.
Enter QC data into Sample Manager (LIMS) and ensure all testing is completed in a timely and compliant manner.
Perform and document equipment maintenance and calibration.
Maintain compliance with company SOPs, specifications, and regulatory standards (FDA, GLP, QSR, cGMP).
Support and document NCRs, CAPAs, and LIRs; act as point of contact for cross-departmental updates.
Participate in cross-functional teams to improve production efficiency, solve technical problems, and reduce costs.
Conduct laboratory and manufacturing audits and update SOPs as needed.
Maintain GMP compliance in all environmental monitoring activities and adhere to EHS and 6S standards.
Perform additional duties as assigned, including occasional weekend work to meet production schedules.
Qualifications:
Bachelor’s degree in Microbiology, Biology, or a related scientific field.
1–2 years of experience in the pharmaceutical or medical device industry preferred.
Strong organizational and multitasking skills; ability to meet deadlines.
Proficiency with laboratory equipment, Microsoft Office, and LIMS systems.
Excellent attention to detail, documentation practices, and verbal/written communication skills.
Familiarity with applicable cGMP, GDP, EHS, and FDA regulatory requirements.
Ability to learn new laboratory systems and technologies quickly.
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Job Title:
Analyst I, Quality Control Lab – Microbiology
Summary:
The Quality Control (QC) Microbiology Analyst is responsible for performing environmental monitoring, microbiological testing, and data analysis to support manufacturing operations in compliance with FDA, GLP, QSR, and cGMP regulations. This role ensures product quality, maintains data integrity, and contributes to continuous improvement initiatives within the QC laboratory.
Key Responsibilities:
Perform environmental monitoring in ISO 5, 7, 8, and 9 cleanrooms and collect water samples.
Conduct microbiological testing on raw materials, in-process, and finished product samples.
Support assays such as endotoxin testing, bioburden analysis, and growth promotion.
Read and interpret microbial plates and record test results accurately.
Enter QC data into Sample Manager (LIMS) and ensure all testing is completed in a timely and compliant manner.
Perform and document equipment maintenance and calibration.
Maintain compliance with company SOPs, specifications, and regulatory standards (FDA, GLP, QSR, cGMP).
Support and document NCRs, CAPAs, and LIRs; act as point of contact for cross-departmental updates.
Participate in cross-functional teams to improve production efficiency, solve technical problems, and reduce costs.
Conduct laboratory and manufacturing audits and update SOPs as needed.
Maintain GMP compliance in all environmental monitoring activities and adhere to EHS and 6S standards.
Perform additional duties as assigned, including occasional weekend work to meet production schedules.
Qualifications:
Bachelor’s degree in Microbiology, Biology, or a related scientific field.
1–2 years of experience in the pharmaceutical or medical device industry preferred.
Strong organizational and multitasking skills; ability to meet deadlines.
Proficiency with laboratory equipment, Microsoft Office, and LIMS systems.
Excellent attention to detail, documentation practices, and verbal/written communication skills.
Familiarity with applicable cGMP, GDP, EHS, and FDA regulatory requirements.
Ability to learn new laboratory systems and technologies quickly.
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