Quality Assurance Associate jobs in United States
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Planet Pharma · 7 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.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

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

CGMP knowledgeRAMAN technologyQuality documentationInspection skillsTraining ability

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

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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 Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase