What are the responsibilities and job description for the Sr Associate Manufacturing - Thousand Oaks 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.
Senior Associate Manufacturing
What you will do
Let’s do this! Let’s change the world!
Responsibilities
The Manufacturing Senior Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Senior Associate position will be focused on:
Characterization, data, and equipment management
Process improvement projects/assignments within operations
Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support
Support new product introduction activities
Support production
Maintain open communication between operations teams
This Senior Associate position will be focused on manual visual inspection operations.
Job Scope And Responsibilities
Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures
May schedule operations for multiple functional areas
Understand process parameters and can identify process anomalies
Perform data analysis of critical process parameters
Operate complex critical processing equipment
Assist, plan and implement continuous improvement solutions related to routine functions
Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks
Primary resource related to processing operations on the mfg. floor
Identify and propose solutions to complex problems
Responsible for resolving problems during operations
Perform initial review of manufacturing procedures/batch records
Review, revise, and audit documents
Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
Provide process theory expertise and hands-on training to others
Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
Applies research, information gathering, and interpretation skills to problems of diverse scope
Utilizes project management skills to set project timelines and priorities based project objectives and ongoing assignments
Recognizes and escalates problems
Able to establish working relationships with others outside area of expertise
Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position
Organizational skills and an ability to perform assignments with a high degree of attention to detail
Written and oral communication skills. Technical writing capability
GMP knowledge with ability to interpret and apply applicable regulations
Auto req ID
474097BR
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 dynamic professional we seek is an employee with these qualifications.
Basic Qualifications
Master’s degree OR
Bachelor’s degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR
Associate’s degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR
High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
Preferred Qualifications
Prior experience with lab equipment, computers, and intermediate mathematical skills
Significant experience with manual visual inspection in a GMP regulated environment.
Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
Demonstrated technical writing skills
Strong knowledge of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
Demonstrated ability to work in a team
Salary Range
86,048.05USD -116,417.95 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.
Senior Associate Manufacturing
What you will do
Let’s do this! Let’s change the world!
Responsibilities
The Manufacturing Senior Associate position is part of the Amgen, Thousand Oaks, Drug Product Supply organization. This is a manufacturing support role responsible for manual visual inspection team. This Senior Associate position will be focused on:
Characterization, data, and equipment management
Process improvement projects/assignments within operations
Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support
Support new product introduction activities
Support production
Maintain open communication between operations teams
This Senior Associate position will be focused on manual visual inspection operations.
Job Scope And Responsibilities
Under minimal supervision, performs manufacturing unit operations according to Standard Operating Procedures
May schedule operations for multiple functional areas
Understand process parameters and can identify process anomalies
Perform data analysis of critical process parameters
Operate complex critical processing equipment
Assist, plan and implement continuous improvement solutions related to routine functions
Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks
Primary resource related to processing operations on the mfg. floor
Identify and propose solutions to complex problems
Responsible for resolving problems during operations
Perform initial review of manufacturing procedures/batch records
Review, revise, and audit documents
Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)
Provide process theory expertise and hands-on training to others
Own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents
Applies research, information gathering, and interpretation skills to problems of diverse scope
Utilizes project management skills to set project timelines and priorities based project objectives and ongoing assignments
Recognizes and escalates problems
Able to establish working relationships with others outside area of expertise
Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)
Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles as appropriate for the position
Organizational skills and an ability to perform assignments with a high degree of attention to detail
Written and oral communication skills. Technical writing capability
GMP knowledge with ability to interpret and apply applicable regulations
Auto req ID
474097BR
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 dynamic professional we seek is an employee with these qualifications.
Basic Qualifications
Master’s degree OR
Bachelor’s degree and 6 months of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR
Associate’s degree and 2 years of experience in biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) OR
High School Diploma/GED and 4 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)
Preferred Qualifications
Prior experience with lab equipment, computers, and intermediate mathematical skills
Significant experience with manual visual inspection in a GMP regulated environment.
Significant experience with PAS X Werum software for electronic batch records with some understanding of editing and validation
Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology
Demonstrated technical writing skills
Strong knowledge of manual visual inspection or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)
Demonstrated ability to work in a team
Salary Range
86,048.05USD -116,417.95 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Salary : $75,000 - $100,000