Specialist QA- 35327 (3rd Shift)

CIS International•Juncos, PR

3d•Onsite

About The Position

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision. This role involves executing Quality disposition (approval or rejection) of bulk drug substances and providing 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. The Specialist QA will ensure that deviations, changes, and production records meet cGMP requirements, and that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices. This role also champions continuous improvement, ensures training completion, collaborates cross-functionally, supports audits and inspections, alerts management to risks, and provides support 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. 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. High school diploma / GED and 10 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment.
Project management skills.
Strong organizational skills, including ability to follow assignments through to completion.
Initiate and lead cross functional teams.
Enhanced skills in leading, influencing and negotiating.
Strong knowledge in area of expertise.
Collaborate and coordinate with higher level outside resources.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Demonstrate ability to interact with regulatory agencies.
Strong word processing, presentation, database and spreadsheet application skills.
Strong communication (both written and oral), facilitation and presentation skills.
Strong skill in working independently and to effectively interact with various levels.
Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Demonstrate the Amgen Values/Leadership Practices.

Nice To Haves

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.

Responsibilities

Review and approve product MPs.
Approve process validation protocols and reports for manufacturing processes.
Request Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Designee for QA manager on local CCRB.
Review Risk Assessments.
Support Automation activities.
Support facilities and environmental programs.
Review and approve Work Orders.
Review and approve EMS/BMS alarms.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
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).