Packaging Technician Lead

Tris Pharma•Monmouth Junction, NJ

1d•$23 - $28•Onsite

About The Position

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. This position is temporary to potential hire opportunity, based on company needs and successful performance. Located in Monmouth Junction, NJ, Tris has immediate openings for (2) Packaging Technician Leads for 2nd SHIFT. Shift is 4 days/week for 10 hrs. Mon-Thurs, Hours are 3:00 pm – 1:00 am The Packaging Technician Lead is responsible for supporting and assisting in the packaging of a range of pharmaceutical products in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates, sets-up, and maintains various pharmaceutical packaging equipment as assigned, and thoroughly and accurately documents all activities to ensure compliance with regulatory guidelines. The incumbent collaborates closely with the Supervisor, Packaging and may be asked to perform many senior and supervisory packaging functions/initiatives in the supervisor’s absence including, but not limited to coordination of daily packaging activities and supervision of safety and workflow, etc.

Requirements

High school diploma or equivalent REQUIRED
Ability and willingness to learn manufacturing procedures and federal regulations pertaining to manufacturing processes REQUIRED
Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc. REQUIRED
Strong record keeping skills/ability REQUIRED
Excellent verbal and written communication and skills REQUIRED
High school diploma or equivalent AND minimum 5 years experience working in a pharmaceutical or biotechnology cGMP regulated environment.
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.
Proficiency with Microsoft Office
Excellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Fluent in English (verbal and written)
Ability and willingness to work additional hours as required by business needs
Ability to lift up to 50 lbs
Ability to use Personal Protective Equipment (PPE)
Ability to stand for extended periods

Nice To Haves

Solid dose manufacturing experience
Associates degree or some college coursework

Responsibilities

Supports and assists in the packaging of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications
Performs the day to day activities of the packaging process as assigned; Operates various types of Packaging equipment including, but not limited to: fillers, cappers, labelers, cartoners, bundlers, shrink wrappers, etc. to ensure efficient packaging of goods
Assists in set up, change over and test runs of equipment for various sized batches and various products, as needed
Collaborates with other production staff and departments
Accurately and consistently completes and documents batch records and other required paperwork
Precisely follows work orders and specifications
Adheres to all plant safety policies and procedures
Assists with organization of daily schedule and assigns personnel to the various workspaces to meet the demand of planning
Reports and investigates any deviations from processes or procedures
Maintains a presence on the packaging floor at all times, Trains new employees and mentors lower-level technicians, as appropriate
May assist with the development and writing of SOPs and investigation reports and contributes to the circulation of the documents under approved procedures
Assists in maintaining a safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources, maintaining compliance with established policies and procedures
Works extra hours or weekends as required by management to meet the demands of the schedule