Senior Associate Manufacturing Services (Day Shift) Holly Springs,NC
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Job Location:
Holly Springs, MS - USA
Monthly Salary:
$ 106188 - 106188
Posted on:
11-11-2025
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.
Senior Associate Manufacturing Services (Day Shift)
What you will do
Lets do this. Lets change the this dynamic role you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule is a rotatinghour Senior Associate will be executing operations on the floor in Manufacturing Services areas and is responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
The Senior Associate is responsible for executing on-the-floor operations within manufacturing 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
Initiate deviation reports
Interact with regulatory agencies as needed and guided
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 EBR)
Complete washroom activities: cleaning equipment small to large scale used in production activities
Identify recommend and implement innovative process improvements and optimizations related to daily routine functions
Assist in the review of 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
Responsible for recognizing and elevating problems during daily operations
Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
Drive safety in all operations and assist the manager in escalating concerns as needed
Maintain an organized clean and workable space
Administrative:
Draft and revise documents (SOPs technical reports and MPs)
Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.
Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.
Senior Associate Manufacturing Services (Day Shift)
What you will do
Lets do this. Lets change the this dynamic role you will be a Senior Associate in the manufacturing organization at Amgen North Carolina (ANC). The schedule is a rotatinghour Senior Associate will be executing operations on the floor in Manufacturing Services areas and is responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
The Senior Associate is responsible for executing on-the-floor operations within manufacturing 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
Initiate deviation reports
Interact with regulatory agencies as needed and guided
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 EBR)
Complete washroom activities: cleaning equipment small to large scale used in production activities
Identify recommend and implement innovative process improvements and optimizations related to daily routine functions
Assist in the review of 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
Responsible for recognizing and elevating problems during daily operations
Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
Drive safety in all operations and assist the manager in escalating concerns as needed
Maintain an organized clean and workable space
Administrative:
Draft and revise documents (SOPs technical reports and MPs)
Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process
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 professional we seek is a team player with these qualifications.
Basic Qualifications:
High School Diploma/GED 4 years manufacturing and/or other regulated environment experience OR
Associates Degree 2 years manufacturing and/or other regulated environment experience OR
Bachelors Degree 6 months manufacturing and/or other regulated environment experience OR
Masters Degree
Preferred Qualifications:
Completion of NC BioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other 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 other electronic systems such as EBR/MES Delta V and Electronic Quality Systems
What you can expect of us
As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.
In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Salary Range
88378.00 USD - 106188.00 USD
Required Experience:
Senior IC
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
