Quality Assurance Specialist jobs in United States
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Planet Pharma · 6 hours ago

Quality Assurance Specialist

Planet Pharma is a company focused on quality assurance in the pharmaceutical sector. The role involves providing oversight of Commissioning, Qualification, and Validation (CQV) processes and ensuring compliance with quality systems in various GMP areas.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures
Participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports
Provides guidance and sets standards in producing quality documentation
Serves as an advisor to Engineering, IS and Manufacturing functions
Provides testing and IT compliance guidance
Provides timely and effective response and follow-through in the resolution of IT compliance issues
Executes quality oversight directly in Quality systems

Qualification

GMP operationsQuality SystemsProject managementAseptic principlesEffective communicationOrganizational skillsTeam player

Required

Bachelors degree in engineering, Biochemistry, Biology, Chemistry, or related science field
Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices
Experience managing projects through completion while meeting timelines
Evaluating documentation and operations according to company procedures and related regulations
Experience working with Quality Systems
Strong organizational skills and ability to manage multiple tasks at one time
Effective communication skills (both written and verbal)
Demonstrated ability to work as both a team player and independently
Solid understanding and application of aseptic behaviors and principles

Preferred

Experience working with Quality Systems
Solid understanding and application of aseptic behaviors and principles

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