Quality Assurance Associate- Immediate Opportunity in South Plainfield at Jobot
South Plainfield, NJ 07080
About the Job
Quality Assurance Associate
This Jobot Job is hosted by: Andrew Kraig
Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
Salary: $60,000 - $80,000 per year
A bit about us:
We are an analytical testing laboratory with over 36 years of industry experience. They provide a comprehensive range of analytical laboratory services to the pharmaceutical, nutraceutical, and cosmetic industries.
Our mission is to be the complete solution for the biopharmaceutical industry’s Analytical Testing and Research and Development needs. The Team prides itself on staying informed and ahead of the changing regulatory landscape. They pledge to serve their clients by providing them with accurate results, in an expeditious manner, with competitive pricing for their formulation, testing, and research and development needs.
Why join us?
Job Details
The Quality Assurance Associate is responsible for reviewing laboratory processes, data, and reports of chemical testing using established methods for OTC drug, cosmetic, dietary supplement, and Rx drug products in a FDA cGMP environment for various clients.
Responsibilities:
You should have most of the following:
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Andrew Kraig
Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
Salary: $60,000 - $80,000 per year
A bit about us:
We are an analytical testing laboratory with over 36 years of industry experience. They provide a comprehensive range of analytical laboratory services to the pharmaceutical, nutraceutical, and cosmetic industries.
Our mission is to be the complete solution for the biopharmaceutical industry’s Analytical Testing and Research and Development needs. The Team prides itself on staying informed and ahead of the changing regulatory landscape. They pledge to serve their clients by providing them with accurate results, in an expeditious manner, with competitive pricing for their formulation, testing, and research and development needs.
Why join us?
- Full Benefits: Medical, Dental, Vision
- Competitive salary and overall compensation package
- 401 (k) with generous company match
- Life Insurance coverage
- Generous PTO, vacation, sick and holidays
Job Details
The Quality Assurance Associate is responsible for reviewing laboratory processes, data, and reports of chemical testing using established methods for OTC drug, cosmetic, dietary supplement, and Rx drug products in a FDA cGMP environment for various clients.
Responsibilities:
- Review analytical raw data to ensure conformance to specifications and ensure documentation in compliance with Standard Operating Procedures (SOPs), cGMP regulations and FDA guidelines.
- Issue Certificate of Analysis after full review of analytical raw data.
- Critically review and release data packages and technical reports produced by Laboratory Team to assure compliance with SOPs and FDA cGMP standards
- Review reports for Method Validation, Method Verification, raw data of API, raw materials, finished products.
- Ensure Standard Operating Procedures (SOPs) and all method documentation is up to date and compliant per FDA cGMP/GLP requirements
- Assist Lab Team and Client Relations to investigate, troubleshoot, and resolve out of specification (OOS) results
- Review equipment/instrument logbooks to ensure accuracy and completeness.
- Assure all documentation (hard copy and digital) is complete, compliant, and of adequate quality to withstand FDA audit
- Assist QA manager in Internal Audits and inspection readiness activities of external audits.
- Identify training needs for chemists in documentation to ensure compliance.
- Ensure compliance with Company’s policies and QMS requirements
- Assist QA Team in upgrading/implementing new QMS, documentation, and change control solutions
- Independently manages own day-to-day activities to support Lab and Quality objectives
You should have most of the following:
- BS in Chemistry with 3+ years experience working in an FDA-regulated analytical laboratory
- A strong understanding of cGMP/GLP requirements and QA procedures for an analytical laboratory
- Experienced with reviewing raw data, Lab data packages, reports, and SOPs
- Experience in OOS investigations to identify root cause analysis.
- Experience in Change control and writing Deviation reports.
- Solid understanding of a variety of analytical chemistry methods such as LC, GC, IR, UV, dissolution, viscosity, melting point, and others
- Experience with the analysis and GMP reporting process of OTC drug, cosmetic, dietary supplement, and/or botanical products
- Strong technical writing skills
- Independent, yet a great team player
- Organized and able to plan work efficiently and effectively
- Ability to consistently deliver on-time results for clients
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
60,000 - 80,000 /year