QA Operations Supervisor
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 QA Operations Supervisor in our Monmouth Junction, NJ facility.
The Quality Assurance (QA) Operations Supervisor works directly with the Quality and Compliance team and collaborates closely with Operations, Manufacturing and other teams within the organization to ensure product quality standards are achieved in accordance to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and batch record specifications.
• Provides timely and careful review of routine and complex QA work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements; Escalates issues as necessary and partners with other cross functional teams ( i.e., operations, manufacturing, etc.) to correct issues
• Writes, updates and/or revises SOPs and troubleshoots issues that may arise during operations/in-coming inspection
• Reviews and evaluates investigations of product complaints and process related errors
• Provides scheduling, supervision and coaching to the QA Inspectors on designated shift(s)
• Executes in-coming inspection of all raw material/components
• Performs in-process inspections
• Provides clearance for rooms/lines to run
• Promptly communicates with/to appropriate departments regarding complaints, product issues/variances
• Works extra hours or weekends as required by management to meet the demands of the schedule
Minimum education and years of relevant work experience
High School diploma or equivalent AND minimum 10 years related work experience OR Associates degree AND 7 years related work experience OR Bachelors degree AND minimum 5 years related work experience . Related work experience must include multiple aspects of the quality process in a pharmaceutical or biotechnology cGMP regulated environment.
Special knowledge or skills needed and/or licenses or certificates REQUIRED
• Working knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes
• Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs
• Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.
• Experience conducting investigations
• Hands on experience with SOP creation and modification
• Proficiency with Microsoft Office
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.