What are the responsibilities and job description for the Manufacturing Specialist - Thousand Oaks CA position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, 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.
Specialist Manufacturing
What you will do
Let’s do this. Let’s change the world. In this vital role you will investigate deviations in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. These investigations are aligned with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Responsibilities
Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
Drive improvements to the investigation process
Defend investigations to regulatory inspectors and internal auditors
Present complex topics clearly to large and small groups at all levels in the company
Build effective relationships across functions
Clear and concise technical writing
Auto req ID
478104BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Doctorate degree
Or
Master’s degree and 2 years of manufacturing experience
Or
Bachelor’s degree and 4 years of manufacturing experience
Or
Associate’s degree and 8 years of manufacturing experience
Or
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications
5 years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Degree in Science or Engineering
Experience leading complex investigations
Demonstrated project management ability
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Salary Range
107,545.40USD -145,502.60 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, 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.
Specialist Manufacturing
What you will do
Let’s do this. Let’s change the world. In this vital role you will investigate deviations in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. These investigations are aligned with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Responsibilities
Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
Drive improvements to the investigation process
Defend investigations to regulatory inspectors and internal auditors
Present complex topics clearly to large and small groups at all levels in the company
Build effective relationships across functions
Clear and concise technical writing
Auto req ID
478104BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Doctorate degree
Or
Master’s degree and 2 years of manufacturing experience
Or
Bachelor’s degree and 4 years of manufacturing experience
Or
Associate’s degree and 8 years of manufacturing experience
Or
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications
5 years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Degree in Science or Engineering
Experience leading complex investigations
Demonstrated project management ability
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Salary Range
107,545.40USD -145,502.60 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Salary : $75,000 - $100,000