Planet Pharma · 1 day ago
QC Analyst II
Newark, CA
Full-time
Onsite
Entry, Mid Level
$30/hr - $42/hr
2+ years expPlanet Pharma is a company focused on pharmaceutical and biotechnology solutions, and they are seeking a QC Analyst II to ensure product quality and patient safety through environmental monitoring and microbiological testing. The role involves working in a GMP environment to perform various testing and documentation tasks, collaborating with Manufacturing and QA teams.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
Perform environmental monitoring, sampling, and analysis of production clean zones using particle counters, contact plates, swabs, and microbial air samplers
Perform utility water sampling and testing (conductivity, TOC, bacterial endotoxins, and bioburden)
Perform microbiological testing such as microbiological examination, endotoxin, growth promotion, etc
Perform sample log-in, assignment of sample tracking number, and coordinate shipment of samples to outside test labs
Perform QC Laboratory testing accurately, according to schedule, and as per written procedures
Record all data, observations, and QC results accurately with attention to detail
Accurately document all data in assay worksheets, laboratory notebooks, and electronic systems (e.g., LIMS) in accordance with ALCO+ data principles and cGMP guidelines
Other duties as assigned
Work independently as well as collaboratively within the QC department and cross-functional departments
Support aseptic process validations and gown certification processes in coordination with manufacturing staff and Quality Assurance
Performs enumeration, characterization, and speciation of microorganisms recovered from samples
Provide lab maintenance and support to ensure cGMP compliance on a regular basis
Take full responsibility in completing/reviewing data packets, test procedures, SOPs, and other controlled documents in a detailed and accurate fashion
Additional responsibilities include peer reviewing laboratory documentation for accuracy, performing routine laboratory and equipment maintenance in accordance with policies and procedures, and supporting documentation management
Support team members to meet group goals
Participation in special projects and/or instrument problem-solving as needed
Qualification
Required
At minimum, 2+ years of microbiological, biological, and chemical method execution within a GMP environment
Experience with aseptic manufacturing principles, pharmaceutical water system, and environmental monitoring programs
Previous cGMP, solid technical training, and troubleshooting experience
Bachelor of Science in Microbiology, Biology, or a related pharmaceutical biotechnology discipline
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
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
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase