QA Training 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.

We have a position in Monmouth Junction, NJ for a Quality Assurance Training Specialist.

The Specialist, Quality Assurance (QA) Training supports and assists the organization in ensuring all appropriate personnel are trained in current, effective policies and procedures in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards The incumbent also provides operational and administrative support for all non-GMP company training programs/initiatives and collaborates closely with individual department management to assure appropriate programs/initiatives have approved syllabus and courses are scheduled, conducted, and tracked in a timely, accurate, effective and compliant manner using Master Control Learning Management System (LMS). 

• Maintains all appropriate Quality related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs

• Works with department management to create and maintain training syllabus/courses and ensures department approved training syllabus is accurately reflected in MasterControl

• Develops and manages cGMP required training per industry and regulatory requirements; Reviews and establishes new cGMP training requirements per industry standard and trend and revises current training procedures, as needed

• Manages employee cGMP training through LMS; Ensures all job codes and training courses in MasterControl are accurate and up to date

• Continually analyzes and assesses quality and compliance training needs within defined areas of business and suggests revisions to training program, as needed; Collaborates closely with department heads on routine review of cGMP training strategy to ensure curricula and On the Job (OJT) training remains current

• Responsible for Administration of SOP and OJT training to ensure consistent and effective training 

• Delivers New Hire cGMP training; Conducts and updates appropriate, annual cGMP training; Creates, updates and conducts current Good Documentation Practices (cGDPs) training, as needed

• Generate periodic quality metrics (monthly or quarterly) pertaining to cGMP training program 

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

· Bachelors degree and minimum 3 years cGMP experience in the pharmaceutical or biotechnology industry 

• Current working knowledge of cGMPs in the pharmaceutical industry

• Working knowledge and hands on experience with LMS maintenance in a cGMP environment

• Training experience

• Strong presentation skills and the ability to clearly and concisely organize and conceptualize complex technical information to technical and non-technical audiences of various sizes 

• Ability to quickly learn new technology

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. 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-hybrid