What are the responsibilities and job description for the Quality Assurance Associate position at Neeyaan LLC?
Overview
We are seeking a detail-oriented Quality Assurance Associate to join our team. The ideal candidate will be responsible for ensuring the quality and compliance of products through various inspection and testing processes.
Qualifications
- Bachelor’s degree required, preferably in a scientific discipline;
- Three (3) years of progressive experience in a GMP environment required;
- Minimum of One (1) to two (2) year of Quality Assurance experience in support of GMP production required;
- Working knowledge of GMPs and their application to pharmaceutical manufacturing required;
- Must be able to interpret applicable standards and objectively make decisions with support of management;
- Excellent verbal and written communication skills
- The employee is frequently required to sit (85%), stand, and walk (15%); use of hands to finger, handle or feel writing tools and computer keyboard; may reach with hands and arms and infrequently may lift up to 30lbs; uses desk telephone/cell phone to talk and hear or converses with other employees
Job Responsibilities
- Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies;
- Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities;
- Recommend changes to SOPs and batch records as needed
- Review proposed SOP revisions and provide constructive feedback
- Conduct real-time audits of batch records for completeness, documentation accuracy, and adherence to critical process parameters
- Perform room and equipment clearances following cleaning procedures
- Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities;
- Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement;
- Initiation of Discrepancies, including Deviations and Investigations;
- Support of implementation of CAPA as determined through Discrepancies;
- Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods;
- Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials);
- Provide basic support during compliance inspections conducted by external sources (i.e. health authorities);
- Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
Job Types: Full-time, Contract, Temp-to-hire
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Monday to Friday
- Weekends as needed
Work Location: In person
