Description:

This individual will be spending 100% of their time in a cleanroom environment long term. At this time it is about 75% desk work since they are still in the production stage. This position will consist of transforming the frozen plasma into freeze-dried plasma.

They will be walking into the freezer to grab the frozen plasma and put it into a machine that will thaw it out. Once this is completed they will transfer the liquid plasma into another bag to put it into the lyophilizer for 7 days to extract all of the moisture to turn it into a freeze dried substance. They will repackage the plasma in the kitting room after that. Every unit is tracked in a BECS system, so attention to detail and experience in a GMP environment is needed.

When they are not spending their time in the cleanroom they will be reviewing procedure and redlining the production procedure to continuously improve it. At this point in time the majority of their time is spent working at the desk.

Champion a safety driven culture. Ensure compliance with all safety and environment regulations.

Manufacture, inspect, and package products following written processes.

Work at a pace that meets, or exceeds, established time standards while making quality product.

Build, inspect and package product following written procedures and using applicable equipment to perform basic visual, dimensional, time and documentation checks, while meeting established timed standards and production goals.

Identify quality issues or workmanship deficiencies related to equipment, assembly and inspection processes, materials, sub-assemblies, and manufacturing environment.

Comply with GMP requirements by maintaining individual training records, completing data entry in production records in a timely and accurate manner, and adhering to documented manufacturing practices and procedures.

Maintain a clean, safe and organized work environment.

Comply with all policies and procedures.

Cross-train across multiple product lines following the Teleflex program.

Perform other duties as assigned.

Additional Skills & Qualifications:

GMP understanding (6 months)

Understands how to follow SOPs

Computer Literate (they will be logging information into a BECS system)

High School Diploma or equivalent strongly preferred

6 months of relevant experience required Biologics, Pharmaceuticals or Medical Devices

Experience in a highly regulated environment preferred.

Must be able to read and understand policies, procedures and processes written in English

Able to communicate effectively through oral and written communication

Responsible for accurate documentation in a highly regulated environment

Able to think critically and make decisions independently

Ability to train operators to applicable manufacturing procedures and train on use of production equipment. Capable of multitasking and switching between tasks frequently

Ability to sit frequently, stand, walk, bend, occasionally lift and go in/out the walk-in freezer

Demonstrated ability to achieve quality and labor time targets required

Requires Hepatitis B shot series or waiver

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com ( actalentaccommodation@actalentservices.com) for other accommodation options.