Manufacturing Associate I/II (Nights)
About the role
The Manufacturing Associate I/II is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The role adheres to written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP).
Responsibilities
- Manufacture bulk intermediates and drug substances per manufacturing batch records and in compliance with quality standards, company policies and current regulations.
- Perform operations in a cleanroom environment, applying controls to ensure aseptic processing including gowning and cleaning procedures.
- Document each task involving manufacturing records and logbooks following GDP at the time of execution.
- Utilize and perform maintenance on equipment per applicable SOP.
- Ensure all materials are issued and accounted for during the execution of a record (i.e. SPR, BPR and Forms).
- Demonstrate, apply, and ensure understanding of cGMP and how it applies to specific tasks and responsibilities.
- Participate and be accountable for workplace organization (5S).
Requirements
- Manufacturing Associate I: Bachelor’s degree in a related scientific or engineering discipline and 0-2 years’ experience in related cGMP manufacturing operations; or high school degree and 3-5 years’ experience, or equivalent.
- Manufacturing Associate II: Bachelor’s degree in a related scientific or engineering discipline and 2-5 years’ experience in related cGMP manufacturing operations; or high school degree and 4-6 years’ experience, or equivalent.
Benefits
KBI offers a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.
Schedule
This position is for a Manufacturing Associate I/II working 6:00 PM - 6:30 AM on a 2 - 2 - 3 Night shift schedule.
Pay
Salary Range:
- Manufacturing Associate I: $26.44 - $36.49
- Manufacturing Associate II: $30.29 - $41.78