QA, Documentation Specialist job in Monmouth Junction
Vacancy has expired
Sign in
Create a candidate account
New Jersey (NJ),
Monmouth Junction
| Job Code: | 2276573 |
| Employer: | Tris Pharma |
| Category: | QA |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Monmouth Junction |
| Post Date: | 02/29/2024 |
| Description | |
|
Job Type Full-time Description 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. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a QA Specialist I/II - Documentation. Job title and level determination will be commensurate with experience. The Specialist I/II, Quality Assurance (QA) Documentation supports and assists the QA function in ensuring manufacturing quality controls and 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. Under the guidance of QA Management, the incumbent assists in completion of all day-to-day, operational tasks required to successfully support operational needs and activities across quality functions of multiple departments including, but not limited to: Quality Control (QC)/Method Validation (MV)/Quality Research and Development (QRD) laboratories, Technical Service, Product Development (PD), Manufacturing and Packaging, QA Operations, etc. She/he may assist in maintenance and tracking of all Quality related documentation including, but not limited to: documentation change requests (Document Change Request (DCR)-Packet (PKT) and Specification, Protocol and Test Method (SPT); Management of Change (MOC) issuance and archival of logbooks and notebooks; inventory, tracking and destruction of documents etc. Responsibilities:
Minimum education and years of relevant work experience: Associates degree or equivalent college and minimum 3 years QA, laboratory or manufacturing experience in the pharmaceutical or biotechnology industry OR combination of education and related QA, laboratory or manufacturing experience in the pharmaceutical or biotechnology industry. Special knowledge or skills needed and/or licenses or certificates required
Special knowledge or skills needed and/or licenses or certificates preferred Bachelors degree in a science related field Travel requirements 0% Physical requirements Office/Manufacturing/ Laboratory based position Ability to lift up to 30 pounds on occasion Ability to use Personal Protective Equipment (PPE) on occasion. Tris Pharma, Inc. offers a highly competitive compensation package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans and women, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI | |
ref: (2276573) 58 days ago
| |
