JOB DESCRIPTION:
*Top Skills:
- Bachelor's degree in Life Sciences Degree is preferred
- Experience in regulatory controlled environments
*Position Summary*
The primary purpose of the Manufacturing Associate role is to complete production assignments with high quality and timely output in a cellular therapeutic manufacturing environment.
*Duties/Responsibilities*
Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
Adheres to Good Manufacturing Practices and standard operating procedures.
Weighs and checks raw materials. Assembles, cleans and sanitizes process equipment, monitors processes.
Completes work instructions and maintains clean room environment to comply with regulatory requirements.
Trains for proficiency in the operation of primary production equipment within the assigned functional area.
Trains for proficiency in process systems (i.e. Syncade MES and Oracle interfaces) and some supporting business systems (i.e. Oracle, ETQ, BMRAM etc.).
Assist with the revision and or creation of process documents, such as SOPs and electronic work instructions.
Assists in maintaining material and components inventory level.
Supports safe work environment.
Work in teams and have continual interaction with members of his/her team as well as other
manufacturing teams throughout the production process in order to exchange information regarding the batch(s) in process.
Works on assignments that are routine in nature where judgment is required in resolving problems and making routine recommendations.
*Qualifications*
Associate s or Bachelor s degree in life sciences field is preferred. Minimum of high school diploma and/or equivalent combination of education and experience is required.
0-2 years of cGMP manufacturing experience is desired or equivalent in work experience or education. Proven experience working on teams where combined contribution, collaboration, and results were expected.
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications. Experience where attention to detail and personal accountability were critical to success.
Demonstrates good interpersonal skills, is attentive and approachable.
Maintains a professional and productive relationship with area management and co-workers
Physical Requirements
Must be able to stand/walk for extended periods of time
Must be able to work in a cleanroom environment and perform aseptic processing, which require gowning and personal protective equipment (PPE), including by not limited to: safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection.
Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials
Required to push and/or pull up to 50 pounds / 25 kg, several times a day, while handling production equipment and/or materials
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