VetJobs
Specialist QA - Allentown, PA
VetJobs, Allentown, PA, United States
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.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Location
Q3 2024 - Q1 2025: Remote or Louisville Distribution Center (LDC), Kentucky
Q2 2025 - Forward: Easton, Pennsylvania - ON-SITE
Specialist QA
What you will do
Let's do this. Let's change the world. In this vital role you will implement and oversee a new Raw Material Center Plus (RMC+) warehouse. RMC+ is a logistics solution being implemented to facilitate raw material network optimization; to serve more manufacturing sites, and to enable inventory pooling and bulk purchasing. RMC+ services will include direct receipt from suppliers, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. This position will be responsible for logistic service provider and transportation service provider oversight, Quality Management System Process alignment, and process improvement activities.
Responsibilities:
Have oversight of small team of QA professionals
Ensure operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety
Collaborate with the LSP to ensure adherence to service levels, identifying performance improvement opportunities in alignment with the Operations READ framework (reliability, efficiency, agility, differentiation)
Implement business continuity for services and processes
Partner with key internal customer groups and/or outside vendors to ensure successful operations
Participate / Conduct quarterly Amgen Business / Quality reviews and address service failures with the LSP
Ensure metric targets are achieved and establish standardized mechanisms to measure progress against targets
Understand and incorporate risk management strategy into overall supply chain strategy
Ensure compliance with required training for staff supporting Amgen business
Provide leadership, guidance, mentorship, and training to staff and partner groups
Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records
Perform incoming raw material inspection, environmental monitoring, and documentation review
Provide leadership updates regarding the health and initiatives relating to the QMS at site management reviews
Provide logistic service provider and transportation service provider oversight
Represent the Quality Unit during audits and inspections and directly interact with regulatory agencies during on-site inspections
Support internal/external audits and inspections as part of the audit/inspection team
Perform routine Quality Assurance assessments of operations and provide direct oversight
Provide quality expertise and guidance to operational staff and within cross functional Amgen teams
Drive operational improvement initiatives, programs, and projects
Develop solutions that are thorough, practical, and consistent with functional objectives
Perform additional duties as specified by management
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have 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:
Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures (excellent written and verbal communication skills)
Self-leadership and motivation
Strategic mindset
Serves as a role model for Amgen Values
Understanding of industry requirements (GMP, GDP, Import/Export)
Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
Previous QA oversight of distribution, warehousing, incoming QA, manufacturing, validation, and facility and engineering activities
Experience in deviation, change controls, and CAPAs processes system knowledge
Ability to evaluate compliance issues and interact with regulatory inspectors
Experience and training in Veeva, SM LIMS, ERP
Experience in managing multiple, competing priorities in a fast-paced environment
Experience leading and/or managing teams
Direct drug substance and/or drug product experience
Ability to solve complex problems and make scientific risk-based decisions
Experience representing Amgen while interacting with representatives of regulatory agencies
Demonstrated proficiency using Excel, Word, and PowerPoint
What you can expect from 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, including remote and hybrid work arrangements, where possible
Salary Range
106,463.00 USD - 125,223.00 USD
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.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Location
Q3 2024 - Q1 2025: Remote or Louisville Distribution Center (LDC), Kentucky
Q2 2025 - Forward: Easton, Pennsylvania - ON-SITE
Specialist QA
What you will do
Let's do this. Let's change the world. In this vital role you will implement and oversee a new Raw Material Center Plus (RMC+) warehouse. RMC+ is a logistics solution being implemented to facilitate raw material network optimization; to serve more manufacturing sites, and to enable inventory pooling and bulk purchasing. RMC+ services will include direct receipt from suppliers, incoming quality inspection and sampling, environmental monitoring, storage, and transportation. This position will be responsible for logistic service provider and transportation service provider oversight, Quality Management System Process alignment, and process improvement activities.
Responsibilities:
Have oversight of small team of QA professionals
Ensure operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety
Collaborate with the LSP to ensure adherence to service levels, identifying performance improvement opportunities in alignment with the Operations READ framework (reliability, efficiency, agility, differentiation)
Implement business continuity for services and processes
Partner with key internal customer groups and/or outside vendors to ensure successful operations
Participate / Conduct quarterly Amgen Business / Quality reviews and address service failures with the LSP
Ensure metric targets are achieved and establish standardized mechanisms to measure progress against targets
Understand and incorporate risk management strategy into overall supply chain strategy
Ensure compliance with required training for staff supporting Amgen business
Provide leadership, guidance, mentorship, and training to staff and partner groups
Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records
Perform incoming raw material inspection, environmental monitoring, and documentation review
Provide leadership updates regarding the health and initiatives relating to the QMS at site management reviews
Provide logistic service provider and transportation service provider oversight
Represent the Quality Unit during audits and inspections and directly interact with regulatory agencies during on-site inspections
Support internal/external audits and inspections as part of the audit/inspection team
Perform routine Quality Assurance assessments of operations and provide direct oversight
Provide quality expertise and guidance to operational staff and within cross functional Amgen teams
Drive operational improvement initiatives, programs, and projects
Develop solutions that are thorough, practical, and consistent with functional objectives
Perform additional duties as specified by management
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have 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:
Ability to liaise/communicate effectively and easily with cross-functional teams and different cultures (excellent written and verbal communication skills)
Self-leadership and motivation
Strategic mindset
Serves as a role model for Amgen Values
Understanding of industry requirements (GMP, GDP, Import/Export)
Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
Previous QA oversight of distribution, warehousing, incoming QA, manufacturing, validation, and facility and engineering activities
Experience in deviation, change controls, and CAPAs processes system knowledge
Ability to evaluate compliance issues and interact with regulatory inspectors
Experience and training in Veeva, SM LIMS, ERP
Experience in managing multiple, competing priorities in a fast-paced environment
Experience leading and/or managing teams
Direct drug substance and/or drug product experience
Ability to solve complex problems and make scientific risk-based decisions
Experience representing Amgen while interacting with representatives of regulatory agencies
Demonstrated proficiency using Excel, Word, and PowerPoint
What you can expect from 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, including remote and hybrid work arrangements, where possible
Salary Range
106,463.00 USD - 125,223.00 USD