Specialist QA - Drug Substance Ops Job at Amgen (Juncos)

Specialist QA - Drug Substance Ops

Amgen

Location:
United States , Juncos

Category:
Quality Control

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

In this vital role you will oversight on-the-floor operations, you will be responsible to ensure that pharmaceutical products are manufactured, tested, stored and distributed according to cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products. Your scheduled workweek may include extended shifts, Saturday and/or Sunday and/or 8/10/12hrs, second or third shift regularly, based on business need.

Job Responsibility:

Execute Quality disposition (approval or rejection) of bulk drug substances
Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations
Ensure that deviations from established procedures are identified, reported, and documented per procedures
Ensure that changes that could potentially impact drug substance quality are assessed according to procedures
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations
Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress
Ensure completion of required training and maintain assigned training adherence to support successful task execution
Collaborate and partner cross‑functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures
Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed
Alert senior management of quality, compliance, supply, and safety risks
Provide support and oversight for New Product Introduction (NPI)

Requirements:

Doctorate degree
or Master’s degree and 2 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
or Bachelor’s degree and 4 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
or Associate's degree and 8 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
or High school diploma / GED and 10 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment

Nice to have:

Educational background in Life Sciences and/or Engineering
Expertise in Quality Systems, including Deviations (Non‑conformities), CAPA, and Change Control
Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP
Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting‑level technical proficiency
Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports
Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations
Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products
Strong organizational skills, with the ability to drive assignments through successful completion
Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues
Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels

What we offer:

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
A discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown

Additional Information:

Job Posted:
January 31, 2026

Employment Type:

Fulltime

Work Type:

On-site work

Amgen - All Job Offers

Job Link Share:

Specialist QA - Drug Substance Ops

Amgen

Location:
United States , Juncos

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 31, 2026

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Job Description:

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