Planet Pharma · 3 hours ago
QC Analyst -Microbiology
Planet Pharma is a company focused on providing quality control solutions in the pharmaceutical industry. They are seeking a QC Analyst in Microbiology to perform environmental monitoring, maintain laboratory supplies, and ensure data integrity within the QC laboratory.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
Participates with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
Responsible for assisting with routine laboratory upkeep and organization
Utilizes GMP systems such as MODA and other laboratory computer systems
Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
Perform all other related duties as assigned
Performs sterility testing and endotoxin testing of raw materials, in-process samples and finished products
Performs growth promotion of microbial media
Prepares environmental monitoring excursion reports and conducts minor laboratory investigations
Assists the QC Supervisor/Leads with managing proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
Maintains familiarity with QC-relevant current Good Manufacturing Practices (cGMP) guidance (CFR, USP, EP, ICH, etc.)
Qualification
Required
Bachelor's degree in biology or relevant scientific discipline required
Minimum 0-2 years relevant laboratory experience or experience in a cGMP and/or FDA regulated industry or a combination of education and related work experience required
Ability to work in Clean Room environment with full gowning requirements
Ability to work independently or as a team member
Detail-oriented with strong written and verbal communication skills
Demonstrated knowledge in Microbiology and aseptic techniques
Ability to problem-solve and troubleshoot as necessary
Bachelors or higher degree in the biological sciences or related field required
Minimum of 1-2 years relevant laboratory experience or experience in a cGMP/FDA regulated industry, or a combination of years of educated and relevant laboratory experience or experience in a cGMP/FDA regulated industry
Demonstrated knowledge in Microbiology and aseptic techniques required
Ability to work independently or as a team member
Ability to work in Clean Room environment with full gowning requirements
Ability to problem-solve and troubleshoot as necessary
Detail-oriented with strong written and verbal communication skills
Preferred
Familiarity with laser particle counters, viable air samplers, microscope, Endosafe® Instrumentation, PCR, BacT/ALERT systems
Familiarity with laboratory data systems such as MODA, LIMS, etc
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Company data provided by crunchbase