What are the responsibilities and job description for the Specialist Quality Assurance Drug Product - 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 Quality Assurance - Drug Product
What you will do
Let’s do this. Let’s change the world. In this vital role you will support the Plant Quality Assurance program providing daily oversight of operational activities associated with and supporting the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Duties include ensuring timely delivery and completion of records within our QMS, i.e. Deviations, CAPAs, Change Controls etc. SOP revision, review and approval, work order approval. The Specialist will also support tech transfers into the facility, evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. The individual will also represent the B20 Quality function of projects necessary to achieve departmental and plant goals and will work in a dynamic cross functional environment.
Responsibilities
Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
Provide Quality support to Tech Transfers into the Drug Product facility.
Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
Perform impact assessments as part of change controls impacting production or QA processes.
Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
Contribute to and drive continuous improvement projects in cross-functional collaboration.
Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
Supports or leads Inspection Readiness for the facility. Participates in internal/external audits and inspections and may directly interact with regulatory agencies during on-site inspections
Auto req ID
468511BR
Minimum Education Required
Bachelors
Job_Category
Scientific Research & Development
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 dynamic employee with these qualifications.
Basic Qualifications
Doctorate degree
Or
Master’s degree and 2 years of quality experience
Or
Bachelor’s degree and 4 years of quality experience
Or
Associate’s degree and 8 years of quality experience
Or
High school diploma / GED and 10 years of quality experience
Preferred Qualifications
Bachelor’s Degree in Science
5 plus years of aseptic processing experience in QA or Manufacturing
Excellent interpersonal, verbal and written communication skills with all levels within the Organization Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions.
Experience applying problem-solving tools for root cause analysis.
Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.
Applies project management principles and techniques.
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, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range
113,191.00 USD - 131,832.00 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$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 Quality Assurance - Drug Product
What you will do
Let’s do this. Let’s change the world. In this vital role you will support the Plant Quality Assurance program providing daily oversight of operational activities associated with and supporting the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Duties include ensuring timely delivery and completion of records within our QMS, i.e. Deviations, CAPAs, Change Controls etc. SOP revision, review and approval, work order approval. The Specialist will also support tech transfers into the facility, evaluate compliance issues, provide recommendations, and assure progress of quality records to completion. The individual will also represent the B20 Quality function of projects necessary to achieve departmental and plant goals and will work in a dynamic cross functional environment.
Responsibilities
Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
Provide Quality support to Tech Transfers into the Drug Product facility.
Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
Perform impact assessments as part of change controls impacting production or QA processes.
Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
Contribute to and drive continuous improvement projects in cross-functional collaboration.
Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
Supports or leads Inspection Readiness for the facility. Participates in internal/external audits and inspections and may directly interact with regulatory agencies during on-site inspections
Auto req ID
468511BR
Minimum Education Required
Bachelors
Job_Category
Scientific Research & Development
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 dynamic employee with these qualifications.
Basic Qualifications
Doctorate degree
Or
Master’s degree and 2 years of quality experience
Or
Bachelor’s degree and 4 years of quality experience
Or
Associate’s degree and 8 years of quality experience
Or
High school diploma / GED and 10 years of quality experience
Preferred Qualifications
Bachelor’s Degree in Science
5 plus years of aseptic processing experience in QA or Manufacturing
Excellent interpersonal, verbal and written communication skills with all levels within the Organization Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions.
Experience applying problem-solving tools for root cause analysis.
Strong leadership capabilities and proven experience applying GMP requirements in an operational setting
Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.
Applies project management principles and techniques.
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, we’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range
113,191.00 USD - 131,832.00 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
Salary : $100,000