Doctorate degree OR Master’s degree & 3 years of Quality experience OR
Bachelor’s degree & 5 years of Quality experience OR Associate’s degree & 10 years of Quality experience OR High school diploma / GED & 12 years of Quality 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 including related Quality Systems (Deviations, CAPAs, Change Controls, etc.).
• 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 Validation.
• 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.
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.
Perform one or more of the following duties and responsibilities in support of client’s Quality Assurance program under minimal supervision.
– 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.
– Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
– 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 client’s Values/Leadership Practices.