Planet Pharma · 13 hours ago
Quality Systems, Contractor
Planet Pharma is a company focused on maintaining compliance and supporting the integrity of Quality Systems. The Coordinator 2, Quality Systems is responsible for managing GxP records, supporting quality event processes, and ensuring compliance with regulatory standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Administer and monitor quality event processes, ensuring conformance to standards, and track operational performance
Sort and categorize records in alignment with retention schedules, regulatory requirements, and company procedures
Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability
Support complaint handling processes by accurately entering product complaint data into the system
Assist with the maintenance and issuance of controlled logbooks
Provide support across Quality System areas, including audits, CAPAs, document control, and training activities
Perform additional duties as assigned to meet departmental and organizational objectives
Qualification
Required
High School Diploma (or equivalent) with 4+ years of experience in life sciences or medical device industry
Strong foundation in records management and regulatory compliance
Familiarity with MasterControl or similar Quality Management Systems
Broad Experience In Quality Functions, Including Customer Complaint Processes
Knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards
Demonstrates integrity, self-confidence, and commitment to prioritizing customer and patient safety
Excellent interpersonal skills; able to collaborate effectively across all organizational levels
Strong work ethic with a proactive approach—eager to learn, take on new responsibilities, and seek additional tasks when available
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