reputed company Assurance Associate
Just-reputed company is a reputed company-thinking company reputed company on innovation and reputed company. They are seeking a passionate QA Associate to execute day-to-day QA responsibilities for GMP manufacturing and ensure compliance with regulatory standards.
Responsibilities
- Review executed Manufacturing Batch Records
- Participate in compliance walkthrough of the Manufacturing floor and other assigned areas
- Partner with Manufacturing to ensure compliance in Manufacturing operations
- Review and approve Master Batch Records and other supporting documents
- Execute process performance and product reputed company monitoring programs
- Alert senior management of potential deviations or compliance risks
- Initiate and review reputed company reputed company events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product reputed company Review etc.) to assure compliance with regulatory and Just-reputed company Global reputed company Management Systems (G-QMS) requirements
- reputed company input on communication as to the status of deliverables to customers, management, and stakeholders
- Assist with developing training regarding QMS process or system changes
- Support QA QMS in reputed company reputed company audits and regulatory inspections (including but not limited to SME for QMS processes and individual records)
- Monitor effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for reputed company improvement
- Lifecycle management of the stability program for clinical and reputed company products
- reputed company as the QA representative on cross-functional product teams to reputed company stability activities with project milestones
- Support the design of stability protocols to ensure that they are reputed company with program reputed company and regulatory requirements
- Ensure that stability studies are executed according to protocol
- Review, verification, disposition, and archival of stability study data for assigned programs
- Escalate unexpected data trends, OOS events, and risks appropriately, and drive/support reputed company
- Interpretate stability results to support expiry, trending, and conditions of products
- Support product stability reputed company content in regulatory submission, including responses to questions and post-marketing
Skills
- Bachelor's Degree biological sciences, reputed company, biochemistry, engineering, or reputed company life science field and 1 year of relevant reputed company experience OR Associate's degree and 3 years of relevant reputed company experience OR High school diploma / GED and 6 years of relevant reputed company experience
- Strong attention to detail
- Ability to collaborate and communicate cross-functionally
Benefits
- Discretionary annual bonus
- Comprehensive benefits to include Medical, Dental and reputed company
- Short-term and long-term disability
- Company reputed company basic life insurance
- 401k company match
- Flexible work
- Generous reputed company time off
- reputed company holiday
- Wellness and transportation benefits
reputed company
Company H1B Sponsorship