What are the responsibilities and job description for the Quality Assurance Specialist - Allentown PA 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.
What you will do
What you will do
Let’s do this! Let’s change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation.
Responsibilities
Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
Review documentation associated with receipt, storage, and distribution
Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership, guidance, mentorship, and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives, programs, and projects targeting operational improvements
Develop solutions that are comprehensive, practical, and align with functional goals
Perform additional duties as assigned by management
Auto req ID
478101BR
Minimum Education Required
High School/GED
Job_Category
Manufacturing
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 individual with these qualifications.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of quality assurance experience OR
Bachelor’s degree and 4 years of quality assurance experience OR
Associate’s degree and 8 years of quality assurance experience OR
High school diploma / GED and 10 years of quality assurance experience
Preferred Qualifications
Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
Expertise in managing deviations, change controls, and CAPAs
Proficiency in Veeva, SM LIMS, and ERP systems
Knowledge of industry standards (GMP, GDP, Import/Export)
Commitment to exemplifying Amgen’s core values
Demonstrated self-leadership and motivation
Strong critical thinking skills
Ability to evaluate compliance issues and engage with regulatory inspectors
Experience managing multiple priorities within a dynamic environment
Direct experience with drug substances and/or drug products
Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
Track record of representing an organization during regulatory interactions
High proficiency in Microsoft Excel, Word, and PowerPoint
Salary Range
104,287.35USD -141,094.65 USD
City*
Allentown
State*
Pennsylvania
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.
What you will do
What you will do
Let’s do this! Let’s change the world!
This onsite position provides critical support for the Raw Material Center (RMC) warehouse, based in Easton, Pennsylvania. The RMC represents an advanced logistics solution designed to optimize the raw material network, serve additional manufacturing sites, and facilitate inventory pooling and bulk purchasing. RMC services encompass direct supplier receipt, incoming quality inspection and sampling, environmental monitoring, storage, and transportation.
Responsibilities
Ensure that all operations align with relevant regulations and Amgen requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices
Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition
Review documentation associated with receipt, storage, and distribution
Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required
Perform routine Quality Assurance assessments and provide direct operational oversight
Offer leadership, guidance, mentorship, and training to staff and partner organizations
Manage oversight of logistic and transportation service providers
Provide expert advice on quality matters to operational teams and cross-functional groups
Ensure staff complete necessary training related to Amgen business operations
Achieve established metric targets and develop standardized approaches for tracking progress
Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement
Participate in quarterly business and quality reviews and address any service failures with LSPs
Present updates on LSP Quality Management System health and initiatives at management reviews
Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies
Support internal and external audits and inspections as a member of the audit/inspection team
Implement business continuity plans for services and processes
Form strategic partnerships with internal customers and external vendors to ensure operational success
Integrate risk management strategies into overall supply chain management
Lead initiatives, programs, and projects targeting operational improvements
Develop solutions that are comprehensive, practical, and align with functional goals
Perform additional duties as assigned by management
Auto req ID
478101BR
Minimum Education Required
High School/GED
Job_Category
Manufacturing
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 individual with these qualifications.
Basic Qualifications
Doctorate degree OR
Master’s degree and 2 years of quality assurance experience OR
Bachelor’s degree and 4 years of quality assurance experience OR
Associate’s degree and 8 years of quality assurance experience OR
High school diploma / GED and 10 years of quality assurance experience
Preferred Qualifications
Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing
Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies
Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions
Expertise in managing deviations, change controls, and CAPAs
Proficiency in Veeva, SM LIMS, and ERP systems
Knowledge of industry standards (GMP, GDP, Import/Export)
Commitment to exemplifying Amgen’s core values
Demonstrated self-leadership and motivation
Strong critical thinking skills
Ability to evaluate compliance issues and engage with regulatory inspectors
Experience managing multiple priorities within a dynamic environment
Direct experience with drug substances and/or drug products
Advanced problem-solving abilities and capacity for scientific, risk-based decision-making
Track record of representing an organization during regulatory interactions
High proficiency in Microsoft Excel, Word, and PowerPoint
Salary Range
104,287.35USD -141,094.65 USD
City*
Allentown
State*
Pennsylvania
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Salary : $75,000 - $100,000