Senior Associate Upstream Manufacturing (Day Shift) Holly Springs, NC
Share
Job Location:
Holly Springs, MS - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
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.
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 work schedule consists of 12-hour day shifts and includes working every other weekend based on business requirements.
The Senior Associates will be executing operations on the floor in our upstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
With general direction the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices.
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 quality non-conformance (NC) 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 innovate process improvements and optimizations related to daily routine functions
Assist in the review of documentation for assigned functions (i.e. equipment logs EBRs ESPs)
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
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.
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 work schedule consists of 12-hour day shifts and includes working every other weekend based on business requirements.
The Senior Associates will be executing operations on the floor in our upstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
With general direction the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices.
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 quality non-conformance (NC) 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 innovate process improvements and optimizations related to daily routine functions
Assist in the review of documentation for assigned functions (i.e. equipment logs EBRs ESPs)
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
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.
Additional Qualifications/Responsibilities
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 BioWork Certificate Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Basic understanding of Upstream operation (Vial Thaw Inoculation/Cell Expansion Single Use Bioreactor Production Bioreactor ATF Harvest Centrifuge Depth Filtration)
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
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
