Amgen · 23 hours ago
Senior Associate Quality Assurance - PQA
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Senior Associate Quality Assurance - PQA role involves providing quality oversight for manufacturing and new product introduction, ensuring compliance with GMP and other regulations while facilitating real-time decision making in a collaborative environment.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Support Quality Control Laboratories IQOQPQ, Equipment Qualification and Validation, perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines
Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support
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
Identification and implementation of continuous improvement opportunities within our processes and systems
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections
Qualification
Required
High school diploma/GED and 4 years of Quality, manufacturing and/or other regulated environment experience OR
Associate's degree and 2 years of Quality, manufacturing and/or other regulated environment experience, OR
Bachelor's Degree and 6 months of Quality, manufacturing and/or other regulated environment experience OR
Master's Degree
Preferred
Strong cGMP and GDP behaviors
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
Demonstrated experience with deviations records
Experience supporting GMP testing laboratories
Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines
Strong communication skills, both written and oral
Demonstrated ability to work as a team player and independently
Benefits
Competitive benefits
Comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
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