Sr Associate Quality Assurance Job at Amgen (Holly Springs)

Sr. Quality Assurance Engineer

The Sr. Quality Assurance Engineer role provides advanced quality engineering su...

Location

Poland , Warsaw

Salary:

Not provided

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in a science or technical field
or Associate’s Degree and 2 years of relevant experience
or High School Diploma or General Education Degree (GED) and 4 years of relevant experience
5 years of relevant job-related experience
Demonstrated ability to perform the essential duties of the position with or without accommodation
fluency in English and communicate effectively in both written and verbal form
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis

Job Responsibility

Lead and execute advanced quality engineering activities including process validation, risk assessments, and supplier quality improvements
Oversee CAPAs, complaints, and audit follow-up activities ensuring timely and effective resolution
Conduct internal and supplier audits, driving corrective actions and continuous improvement initiatives
Provide quality oversight of EQMS documentation to ensure alignment with global standards (21 CFR 820, ISO 13485, EU IVDR)
Mentor junior engineers and technicians on quality system requirements and best practices
Collaborate cross-functionally to evaluate data trends, identify risks, and implement process enhancements across operations

Fulltime

Sr. Specialist I, Product Quality Assurance

The Sr. Specialist I, NC Product Quality Assurance (PQA) will be responsible for...

Location

United States , Durham

Salary:

140000.00 - 185000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in a scientific discipline with 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
Knowledge of aseptic processing, and/or cell and gene therapy is preferred
Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
Knowledge of global regulations and standards
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually as well as within a multi-disciplinary team
Excellent listening, communication and interpersonal skills with a team focus
Consistent delivery of high-quality work
Ability to gown and work in a cleanroom environment

Job Responsibility

Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
Provide Quality oversight of QC testing
Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
Real time review of batch records and labels
Review and approval of manufacturing discrepancies and associated CAPA's
Communicating lot disposition pending issues to management
Aid in the development and ongoing improvement of applicable quality systems for the site
identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
Review and approve calibration and maintenance work orders and asset inductions

Fulltime

Sr. Associate - Outbound Warehouse Operations

In this vital role, you will support outbound warehouse operations responsible f...

Location

United States , New Albany

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years of Supply Chain, Warehouse, Manufacturing, or Operations experience OR Associate's + 2 years of Supply Chain, Warehouse, Manufacturing, or Operations experience OR Bachelor's + 6 months of Supply Chain, Warehouse, Manufacturing, or Operations experience OR Master's degree

Job Responsibility

Execute outbound warehouse operations in compliance with GMP/GDP and EHSS requirements
Support daily outbound activities including order fulfillment, shipping coordination, inventory transfers, staging, and shipment processing
Perform and support SAP warehouse transactions and ensure data accuracy within warehouse systems
Monitor outbound workflows to ensure on-time shipment execution and operational readiness
Support cycle counts, inventory reconciliation activities, and material movements
Identify and escalate operational issues while supporting timely resolution
Participate in investigations, deviations, CAPAs, change controls, SOP revisions, and risk assessments as needed
Collaborate cross-functionally with Packaging, Quality Assurance, Planning, and Logistics teams
Support continuous improvement initiatives using standard operational excellence tools and methodologies
Monitor warehouse KPIs and support reporting activities

What we offer

Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Sr Associate Software Engineer

Amgen is seeking a Sr. Associate Software Developer to contribute to the design,...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 1 to 3 years of Computer Science, IT or related field experience OR Bachelor’s degree and 3 to 5 years of Computer Science, IT or related field experience OR Diploma and 7 to 9 years of Computer Science, IT or related field experience
Hands on experience with various cloud services, understand pros and cons of various cloud services in well architected cloud design principles
Hands on experience with Full Stack software development. Proficient in programming language Python(preferred), JavaScript,React.js/Node.js/Express.js SQL/NoSQL
Strong problem solving, analytical skills
Ability to learn quickly
Excellent communication and interpersonal skills
Experienced with API integration, serverless, microservices architecture.

Job Responsibility

End-to-End Ownership: Take ownership of complex software projects from conception to deployment, managing scope, risks, and timelines
Front-End Development: Design and implement responsive, accessible, and visually appealing user interfaces using HTML, CSS, JavaScript, and modern frameworks (React.js, Angular, or Vue.js)
Back-End Development: Build and optimize scalable server-side logic and APIs using Node.js, Express.js, or Python, ensuring secure integration with databases and microservices
Database Design & Management: Design, develop, and maintain SQL/NoSQL databases, focusing on security, performance, and reliability
API Development: Create RESTful or GraphQL APIs for communication between front-end, back-end, and external systems
Cross-Browser & Cross-Platform Compatibility: Ensure applications run seamlessly across multiple browsers, devices, and platforms
Generative AI & Innovation: Develop innovative solutions leveraging generative AI technologies to enhance applications and workflows
Cloud Deployment & Management: Deploy, manage, and scale applications on cloud platforms (AWS, Azure, GCP)
apply DevOps and CI/CD best practices
Software Architecture & Documentation: Design software architecture and produce technical documentation on system design, deployment, integration, disaster recovery, and operations

Fulltime

Sr Associate QA I

Sr Associate QA I at Amgen in Holly Springs, North Carolina. This is an on-site ...

Location

United States , Holly Springs

Salary:

82081.95 - 111052.05 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school/GED + 4 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Associate's + 2 years Quality Assurance, manufacturing and/or other regulated environment work experience OR Bachelor's + 6 months Quality Assurance, manufacturing and/or other regulated environment work experience OR Master's

Job Responsibility

Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation

What we offer

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

Fulltime

Sr. Associate Systems Analyst

The Sr. Associate Systems Analyst – Clinical Data Hub will collaborate with netw...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s / Bachelor’s degree with 5-8 years of experience in Information Systems Administration/Support/Validation
Experience with GxP-regulated computer system validation
Experience with Agile software development methodologies (Scrum)
Experience with validation solutions, tools, and methodologies

Job Responsibility

Support, monitor, or execute the installation of infrastructure security patches and configuration changes
Review system release notes and identify regression test requirements
Develop detailed test plans and strategies based on release notes, project requirements, and specifications documents
Perform manual and automated testing of software applications, including functional, regression, and performance testing
Document and report defects and issues identified during testing, and work with development teams to resolve them
Maintain detailed documentation of test/validation plans, test cases, and test results
Advise on the documentation of requirements to ensure that they are written in a testable manner
Validate that test scenarios meet feature acceptance criteria and customer expectations
Maintain and ensure the quality of documented user stories/requirements in tools such as Jira
Prepare, execute, document, and report validation protocols in line with GxP’s and other regulatory requirements and standards

Fulltime

Compliance Assurance Sr. Analyst

We are looking for a proactive and detail-oriented professional to join our TCCO...

Location

Philippines , Taguig

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience in a Technology Risk Management, Cyber Risk, Information Security, IT Audit, or a related controls-focused role.
Direct experience in performing compliance testing, assurance, or audits for technology and/or cybersecurity controls.
Strong understanding of the risks and controls related to End-User Computing (EUC) and associated data management.
Solid understanding of IT systems, networks, cloud services, security infrastructure, and system vulnerabilities.
Familiarity with regulatory requirements and enterprise risk management frameworks (e.g., COBIT, NIST, ISO 27001).
Demonstrated experience in the risk management lifecycle, including risk identification, assessment, mitigation, and reporting.
Excellent project management and organizational skills, with the ability to prioritize tasks and manage multiple initiatives effectively.
Strong analytical, problem-solving, and decision-making skills.
Bachelor's/University degree or equivalent experience.

Job Responsibility

Perform independent, full-scope, and targeted compliance tests on technology and cybersecurity controls to assess their design and operating effectiveness.
Conduct regular and comprehensive technology and cyber risk assessments, documenting findings and recommendations to reduce risk exposure.
Assess and test risks associated with End-User Computing (EUC), and IT enabaled Smart Solution (ITeSS) focusing on its principles, cycles and overall governance.
Independently evaluate technology and cyber risks within the business to ensure they are within the acceptable risk appetite, taking proactive measures to address areas of concern.
Build and maintain effective engagement with the 1st Line of Defense, business partners, and other key stakeholders to understand their risk profiles, strategic priorities, and challenges.
Provide expert guidance on technology and cyber risk mitigation strategies and control enhancements.
Participate in initiatives to augment technology and cyber risk management practices. Support the development and implementation of enhanced procedures and methodologies.
Ensure all technology and cyber risk management activities adhere to internal policies, external regulations, and industry standards.
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency.
Analyze data to identify trends, emerging risks, and control gaps, providing timely recommendations to mitigate risk exposure.

What we offer

Programs and services for physical and mental well-being including access to telehealth options, health advocates, confidential counseling and more.
Expanded Paid Parental Leave Policy.
Programs to manage financial well-being and help plan for the future.
Access to an array of learning and development resources.
Generous paid time off packages.
Resources and tools to volunteer in the communities.

Fulltime

Sr Associate Plant QA

If you feel like you’re part of something bigger, it’s because you are. At Amgen...

Location

Netherlands , Breda

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience
Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases
Manufacturing and/or Quality analytical processes and operations
Fluent in the English language

Job Responsibility

Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions
Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations
Review and approve batch production record data entries before production activities take place
Perform finished product checks during (commercial) production runs
Compile and review batch records for lots assembled, packaged, and labeled at ABR and contract manufacturers in preparation for disposition by QP
Review and approve Deviation records

What we offer

Competitive salary
Bonus structure
Fixed 13th month
Holiday allowance
Collective health insurance
On-site gym
Vitality program
Restaurant with healthy food

Fulltime

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Sr Associate Quality Assurance

Job Description

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