VetJobs
Senior Associate Manufacturing Services (Day Shift) - Holly Springs,NC
VetJobs, Holly Springs, North Carolina, United States, 27540
Senior Associate Manufacturing Services (Day Shift) - Holly Springs, NC
Amgen is seeking a Senior Associate in the manufacturing organization at Amgen North Carolina. The schedule is a rotating 2-2-3, 12‑hour shift.
Responsibilities include:
Execute on‑floor operations in Manufacturing Services areas in accordance with cGMP practices.
Initiate deviation reports and interact with regulatory agencies as needed.
Perform hands‑on operations: 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).
Identify, recommend, and implement innovative process improvements related to daily routine functions.
Collaborate with cross‑functional team (QA/QC, Facilities & Engineering, PPIC, Mfg., PD, Regulatory).
Participate in CAPA implementation and continuous improvement.
Maintain an organized, clean, and workable space.
Draft and revise documents (SOPs, technical reports, and MPs).
Qualifications:
High School Diploma/GED + 4 years manufacturing experience OR Associate’s Degree + 2 years OR Bachelor’s Degree + 6 months OR Master’s Degree.
Completion of NC BioWorks Certification Program.
Experience in biotechnology or pharmaceutical plant start‑up.
Knowledge of cGMP manufacturing facility or highly regulated environment.
Strong understanding of solution preparation, equipment preparation, and inventory control operations.
Excellent verbal and written communication (technical) skills.
Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
Salary Range: $88,378.00 – $106,188.00 USD
City: Holly Springs State: North Carolina
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Responsibilities include:
Execute on‑floor operations in Manufacturing Services areas in accordance with cGMP practices.
Initiate deviation reports and interact with regulatory agencies as needed.
Perform hands‑on operations: 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).
Identify, recommend, and implement innovative process improvements related to daily routine functions.
Collaborate with cross‑functional team (QA/QC, Facilities & Engineering, PPIC, Mfg., PD, Regulatory).
Participate in CAPA implementation and continuous improvement.
Maintain an organized, clean, and workable space.
Draft and revise documents (SOPs, technical reports, and MPs).
Qualifications:
High School Diploma/GED + 4 years manufacturing experience OR Associate’s Degree + 2 years OR Bachelor’s Degree + 6 months OR Master’s Degree.
Completion of NC BioWorks Certification Program.
Experience in biotechnology or pharmaceutical plant start‑up.
Knowledge of cGMP manufacturing facility or highly regulated environment.
Strong understanding of solution preparation, equipment preparation, and inventory control operations.
Excellent verbal and written communication (technical) skills.
Proficient Microsoft Office skills and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
Salary Range: $88,378.00 – $106,188.00 USD
City: Holly Springs State: North Carolina
#J-18808-Ljbffr