Be an early applicantLess than 25 applicants

Company

Amgen · 1 day ago

Specialist QA

New Albany, OH

Full-time

Hybrid

Mid, Senior Level

2+ years exp

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Review and approve controlled documents, including Standard Operating Procedures, Validation Protocols, Validation Reports, Electronic Master Batch Records etc.

Provide quality oversight for quality records including deviations/CAPAs, technical change controls and work orders assuring adherence to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate

Ensure that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

Own quality related Standard Operating Procedures, Work Instructions, Forms and Methods

Provide quality oversight for manufacturing and be responsible for batch disposition.

Provide quality and compliance expertise & guidance and agrees on strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment and information systems.

Support and represent Quality during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Support Lean Transformation and Operational Excellence initiatives

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

GMP regulationsQuality OperationsQuality oversightRoot Cause AnalysisValidation documentationLeadership capabilitiesDigital innovationQuality engineering

Required

Doctorate degree

Master’s degree and 2 years of Quality and/or Manufacturing experience

Bachelor’s degree and 4 years of Quality and/or Manufacturing experience

Associate’s degree and 8 years of Quality and/or Manufacturing experience

High school diploma / GED and 10 years of Quality and/or Manufacturing experience

Preferred

Master's or Bachelor’s Degree in Science

Educated in a science field with 5 years of experience in GMP/GCP operations or similarly regulated industry

Affinity with digital innovation, data sciences and Quality engineering

Experience in review/approval validation documentation

Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues

Ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations

Experience working with dynamic cross-functional teams and abilities in decision making

Strong organizational skills, including ability to follow assignments through to completion

Strong leadership capabilities and experience applying GMP requirements in an operational setting

Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

Benefits

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

Company

Amgen

Glassdoor

4.2

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

Founded in 1980

Thousand Oaks, California, USA

10001+ employees

http://www.amgen.com

H1B Sponsorship

Amgen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (349)

2022 (523)