Planet Pharma
Join to apply for the
Specialist I-QA Product Release
role at
Planet Pharma . 3 days ago Be among the first 25 applicants. Get AI-powered advice on this job and more exclusive features. Description
Planet Pharma is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients at risk for infection. We are committed to excellence and integrity in the biopharmaceutical industry and are seeking a
Quality Assurance Specialist I - Product Release
in Boca Raton, FL. The
Quality Assurance Specialist I - Product Release
performs various QA activities to ensure compliance with regulatory requirements, including batch release, documentation review, and process adherence. Qualifications
Understanding of cGMPs and quality systems such as Deviations, CAPAs, Change Controls, and OOSs. Knowledge of regulations like 21 CFR Parts 11, 210, 211, and 600. Ensure batch releases comply with SOPs and supporting documents are complete and accurate. Coordinate with manufacturing and quality teams on batch release priorities and delays. Assist with investigations, CAPAs, and review of manufacturing records and supporting documentation. Discuss and resolve quality issues, review SOP revisions, and support failure investigations. Requirements
Bachelor’s Degree or equivalent experience in pharmaceutical or biotech industry (3-5 years preferred). Additional Information
This is a full-time position. Planet Pharma is an equal opportunity employer fostering diversity and inclusion.
#J-18808-Ljbffr
Specialist I-QA Product Release
role at
Planet Pharma . 3 days ago Be among the first 25 applicants. Get AI-powered advice on this job and more exclusive features. Description
Planet Pharma is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients at risk for infection. We are committed to excellence and integrity in the biopharmaceutical industry and are seeking a
Quality Assurance Specialist I - Product Release
in Boca Raton, FL. The
Quality Assurance Specialist I - Product Release
performs various QA activities to ensure compliance with regulatory requirements, including batch release, documentation review, and process adherence. Qualifications
Understanding of cGMPs and quality systems such as Deviations, CAPAs, Change Controls, and OOSs. Knowledge of regulations like 21 CFR Parts 11, 210, 211, and 600. Ensure batch releases comply with SOPs and supporting documents are complete and accurate. Coordinate with manufacturing and quality teams on batch release priorities and delays. Assist with investigations, CAPAs, and review of manufacturing records and supporting documentation. Discuss and resolve quality issues, review SOP revisions, and support failure investigations. Requirements
Bachelor’s Degree or equivalent experience in pharmaceutical or biotech industry (3-5 years preferred). Additional Information
This is a full-time position. Planet Pharma is an equal opportunity employer fostering diversity and inclusion.
#J-18808-Ljbffr