QA Specialist (Temp)
Tris Pharma, Inc. (www.trispharma.com) is a rapidly growing, technology-driven pharmaceutical company engaged in branded and generic product development located in Monmouth Junction, New Jersey.
We have openings for Pharma Quality Assurance(QA) Specialists or Sr Specialists. These positions are approximately 6 month potential TEMP to hire opportunities based on successful performance and company needs.
QA (SR) Specialists are responsible for supporting the maintenance and tracking of all Quality related documentation including but not limited to: change control, annual product reviews (APRs), Standard Operating Procedure/Form Change Requests (SFCRs), etc. She/he supports adherence to, and compliance with established, company quality policies, practices, SOPs and federal regulations.
• Triage and initiate Notice of Incidents (NOI) for non-conforming events.
• Classifies deviation investigations and assigns ownership to the appropriate Tris personnel for investigation completion.
• Manages review and approval workflow of Deviation Investigations, Corrective/Preventive Actions (CAPA), Planned Deviations (PDRs), and Product Quality Complaint Investigations.
• Reports weekly and quarterly metrics pertaining to Deviation Investigations, Corrective/Preventive Actions (CAPA), Planned Deviations (PDRs), and Product Quality Complaint Investigations to Quality Management; Assist with technical writing of documents, as needed
• Applies requests for change status for materials, finished product, etc. related to investigations.
• Provides support during audits from Regulatory Agencies, Partners/Customers, etc.
• Assist in other areas of Quality Assurance as deemed necessary by Quality Management.Requirements
Associate degree or equivalent college REQUIRED, Bachelors degree is preferred.
· Minimum 3 years experience in the pharmaceutical or biotechnology industry required, preferably in Quality Assurance REQUIRED.
· Current working knowledge of current Good Manufacturing Practices (cGMPs) in the pharmaceutical industry REQUIRED.
· Current, hands-on experience working with/on investigations, change controls and/or CAPAs REQUIRED.
· Proficiency with Microsoft Office including Word, Excel, and Power Point REQUIRED.
· Excellent verbal and written communication and skills REQUIRED.
Tris Pharma, Inc. offers a highly competitive compensation. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI