Skip to main content

This job has expired

You will need to login before you can apply for a job.

QA Specialist (Temp)

Employer
Tris Pharma
Location
Monmouth Junction, NJ
Start date
Dec 1, 2021

View more

Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

  

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 3 - 4 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.  

RESPONSIBILITIES 

• 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

  

JOB QUALIFICATIONS 

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. 

Company

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body;develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large.

Company info
Website
Phone
(732) 940-2800
Location
US Highway 130
Monmouth Junction
NJ
08852
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert