Planet Pharma · 11 hours ago
Quality Assurance Associate
Planet Pharma is a company focused on ensuring quality in manufacturing processes. They are seeking a Quality Assurance Associate to support the inspection, sampling, and testing of raw materials at their North Carolina site, ensuring compliance with specifications and cGMP requirements.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
Remove samples from containers of medias and other chemicals to facilitate the testing of samples
Use RAMAN technology with TruScan equipment to identify chemicals
Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
Responsible for accurately documenting inspection, sample, and test results in systems
Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
Ability to determine the color of components match required attributes
Support inspection readiness activities
Supports Continual Improvement initiatives, programs and projects
Assist area management with the prioritization and scheduling of tasks
Serve as a trainer in tasks associated with raw material inspections, samples, and testing
Own controlled documents for the area including SOPs and FORMs
Initiate and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections, samples, and testing areas
Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations
Qualification
Required
Support the inspection, sampling, and testing of raw materials that are received at the North Carolina (NC) site
Ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process
Demonstrate leadership skills in support of scheduling, coordination, and staff training
Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
Remove samples from containers of medias and other chemicals to facilitate the testing of samples
Use RAMAN technology with TruScan equipment to identify chemicals
Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
Responsible for accurately documenting inspection, sample, and test results in systems
Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
Ability to determine the color of components match required attributes
Support inspection readiness activities
Supports Continual Improvement initiatives, programs and projects
Assist area management with the prioritization and scheduling of tasks
Serve as a trainer in tasks associated with raw material inspections, samples, and testing
Own controlled documents for the area including SOPs and FORMs
Initiate and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections, samples, and testing areas
Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations
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