Planet Pharma · 16 hours ago
Senior Quality Control Associate
Planet Pharma is seeking a Senior Quality Control Associate to execute deliverables for a project implementing a new Electronic Lab Notebook system. The role involves designing, configuring, and validating the ELN system while adhering to safety and regulatory requirements, and collaborating with colleagues to ensure project commitments are met.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Participate in process engineering activities
Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
Participate in system requirement, software configuration, and design activities
Receive and/or verify master data for the site(s)
Coordinate ELN Template development and review with site SMEs
Execute User Acceptance Testing & Data Migration Verification
Review and provide input on training materials
Support training material development by providing inputs and reviews
Support site Instrument Qualification activities such as planning and execution
Qualification
Required
Bachelor's degree and 2 years of industry Quality Control or Quality experience
OR
Associate's degree and 6 years of industry Quality Control or Quality experience
OR
High school diploma / GED and 8 years of industry Quality Control or Quality experience
Preferred
GxP experience, specifically practices and requirements in the testing of biopharmaceuticals
Experience and knowledge in using electronic lab notebook systems (Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.)
Advanced proficiency in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint)
Experience in the use of other industry systems such as Veeva & Empower
Experience in testing or with processes involving analytical methods
Excellent problem-solving capabilities and attention to detail
Experience of collaboration within and across functional areas
Excellent written and verbal communication skills
Experience in development and validation testing of software used in a GMP environment
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
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