Specialist/Sr Specialist, QA

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is a technology driven, specialty pharmaceutical company. With our intense focus on application of physical chemistry in the 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.

Our rapid expansion has created openings for Pharma Quality Assurance(QA) Specialists and Senior Specialists in our QA/Compliance department. Job title and level determination will be commensurate with experience.

These positions support the QA function by ensuring manufacturing quality controls and procedures are followed in accordance to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The incumbent supports and assesses operational needs and activities in order to successfully achieve quality goals and metrics across multiple quality functions including, but not limited to: documentation, compliance, operations, etc. 

She/he may assist in the maintenance and tracking of all Quality related documentation including, but not limited to: Investigations, CAPAs, Planned Deviations, Change Controls, etc.

· Maintains all investigation and CAPA related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs 

• Issues, tracks and closes investigations and CAPAs

• Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System; Tracks and trends appropriate metrics for open CAPAs, planned deviations, product complaints, etc. 

• Reports monthly metrics pertaining to investigations and CAPA to Quality department head and other appropriate company personnel

• Assists with SOP revision and participates in inspections, as needed 

• Assists in other areas of QA and may cross train across department, as needed

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

Associates degree or equivalent college (Bachelors degree preferred) 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.

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

• Current working knowledge of cGMPs in the pharmaceutical industry

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.