Doctorate degree in Sciences/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineer and 8 years of directly related experience.
• Engineering / Science related background.
• Experienced in Aseptic processing manufacturing processes.
• General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).
• Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.
• Direct experience on Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
• Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP
document or project plan.
• Ability to conduct GMP quality inspections, walk downs and general oversight to production, utilities and general facility areas with the objective to ensure the required state of
• Knowledge on general Validation concepts (e.g., Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities
including Computerized Systems) applied to GMP Pharmaceutical production areas required.
• Direct experience supporting multifaceted Validation projects from a Quality perspective and working with multidisciplinary teams on tight execution schedules.
• Ability to analyze, troubleshoot and solve quality related issues on a highly regulated GMP environment.
• General understanding around the process for the introduction of new products and new technology within commercial GMP areas.
• Ability to communicate and escalate quality issues clearly, with the required level of details and on a timely manner.
• Demonstrated ability to follow GMP procedures with a strong Quality and Compliance mindset.
• Project Management skills. Presentation Skills.
• Excellent Technical Writing and general Communication skills in English and Spanish.
• Information/Computer Systems knowledgeable.
• Good interaction skills to enable appropriate performance supporting complex matrix organizations.
• Capable to follow required Environmental Health & Safety procedures and related requirements within a GMP production environment.
• Ability to learn, execute and follow procedures related to Personnel Gowning for access to environmental controlled/classified rooms.
• Experience conducting quality audits to GMP production batch records and related supporting operational compliance documents for review and approval.
• Ability to work in teams and demonstrate full engagement with execution plans and adherence to established due dates.
• Strong engagement and partnership with site Management.
• Administrative Shift – nonstandard
In support of client’s Quality Assurance program acts as the technical specialist.
Review and approve product MP’s.
Approve process validation protocols and reports for mfg. processes.
Represent Quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Approve planned incidents.
Represent QA on NPI team.
Own site quality program procedures.
Designee for QA manager on local CCRB.
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 processes development. Demonstrated 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.