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Manufacturing Associate, Bulk Drug Substance Upstream - Days
Live
What you will do
Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule is a rotating 2-2-3, 5:45AM-6:15PM (12-hour shift). Associates will be completing operations on the floor in our upstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
With general direction, the Associate will support all floor operations in accordance with cGMP practices.
Responsibilities will include...
Compliance:
Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Process/Equipment/Facilities:
Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
Perform documentation for assigned functions (i.e., equipment logs, EBRs)
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
Maintain an organized, clean, and workable space
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications:
High School/GED + 2 years manufacturing and/or other regulated environment experience
Or
Associate's Degree + 6 months manufacturing and/or other regulated environment experience
Or
Bachelor's Degree
Preferred Qualifications:
Completion of NC BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
Salary Range
70,985.20USD -96,038.80 USD