R&D QA Specialist

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open, and honest communications to help support individual and team success. 

Position Summary:

The Research and Development (R&D) Quality Assurance Specialist supports the Compliance function by ensuring R&D laboratory (Product Development and Method Validation) operations, manufacturing testing procedures are followed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (CGMP), Food and Drug Administration (FDA) standards and batch record specifications.  The incumbent supports and assesses R&D needs and activities to successfully achieve compliance goals and metrics across multiple quality functions including, but not limited to documentation, quality, operations, etc. 

She/he may also perform the maintenance, tracking, development and/or execution of all Quality related documentation in the R&D department including, but not limited to investigations, Corrective and Preventive Action (CAPA), Planned deviations (PDR), Pilot/Clinical/Test Batch and submission batch record review, review and/or approval of qualification/validation activities, approval of R&D Change Control Requests (CCRs) and SOP/Form Change Request (SFCRs), etc.

Essential Functions:

· Assign/Maintain code numbers for all components (API, Excipients, Intermediates, Drug product & Packaging/ID numbers for 

the all the equipment required by PD & AR&D 

· Reviews/approves specifications/test methods/protocols/reports for MV

· Reviews/approves Product Development and AR&D Reports

· Issues, tracks, and closes R&D Change Controls, SOP/SFCRs, investigations, CAPAs and PDRs

· Reviews and approves R&D investigations, root cause analysis, CAPA activities, in accordance with the company’s effective procedures

· Tracks and trends appropriate compliance metrics (i.e., R&D Change Controls, SOP/SFCRs, investigations, CAPA and PDRs)

· Maintains and assists with R&D Batch Record Issuance and Control

· Releases raw materials and components used for R&D processes

· Participates in inspections and customer audits, as needed 

· Participates in training and training development

· Performs and/or participates in internal and external audits, as needed

· Review submission data for RA

· Reviews Clinical study documentation prior to release

Requirements/Qualifications: 

Minimum education and years of relevant work experience

Bachelor’s Degree in a scientific discipline, preferably chemistry AND minimum 3 years experience in the pharmaceutical or biotechnology industry OR combination of education and related quality and/or compliance experience in the pharmaceutical or biotechnology industry.

· Special knowledge or skills needed and/or licenses or certificates required

· Current working knowledge of CGMPs in the pharmaceutical industry 

· Experience working with Investigations, Root Cause Analysis, CAPAs and/or Customer Complaints

· Proficiency with Microsoft Office 

· Excellent verbal and written communication and skills

· Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

Special knowledge or skills needed and/or licenses or certificates preferred

· Pharma Analytical laboratory and method validation experience 

Travel requirements

Less than 10%

Office based position