Planet Pharma · 6 hours ago
QA Associate, Quality Operations
Norton, MA
Full-time
Onsite
Entry, Mid Level
$42/hr - $48/hr
2+ years expPlanet Pharma is seeking a QA Associate to ensure that biopharmaceutical products are manufactured to the highest standards. The role involves providing day-to-day QA support across various functions to maintain GMP compliance and inspection readiness.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide raw material support, including review/approval of incoming material documentation and release for GMP use
Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities
Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents
Generate and maintain Quality-related SOPs and controlled forms
Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements
Review and approve QC laboratory qualification documents, including equipment qualification
Perform executed batch record review and approval to ensure accuracy and compliance
Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system
Support partner audits and regulatory inspections, including document retrieval and subject matter input
Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance
Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence
Qualification
Required
Bachelor's degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience
2–4 years of GMP experience in Quality, Manufacturing, or QC
Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices
Strong attention to detail, organizational skills, and the ability to communicate effectively across teams
Preferred
Experience with quality systems (e.g., Veeva, SAP) is a plus
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
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
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase