Specialist QA (31671) – Juncos, PR

Requirements Education & Experience
Doctorate degree or Master’s degree & 3 years of Quality experience OR
Bachelor’s degree & 5 years of Quality experience OR
Associate degree & 10 years of Quality experience OR
High school diploma / GED & 12 years of Quality experience

Highly preferred: Industrial Microbiologist, Environmental Microbiologist

Preferred Qualifications:
• Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of sterile biological products.
• Experience working with Quality Systems functional area (e.g., deviations, CAPAs, Changes Controls, etc.) and at site Quality Oversight programs.
• Experience conducting trending, monitoring an oversight of cleaned, controlled, and classified environments for sterile and non-sterile manufacturing areas.
• Proficient establishing environmental control procedures and assessing adequate gowning systems to personnel interacting within controlled environments.
• Capable to troubleshoot contamination events and determine action plans, propose compliant solutions to address complex contamination control problems and develop expert protocols to mitigate quality and operational contamination situations (e.g., cleaning and sanitation procedures, disinfectants implementation and qualification, microbiological samplings, and techniques for adequate contamination control prevention).
• Capable of solving problems related to microbial growth within industrial pharmaceutical controlled environments.
• Apply statistical tools and methodologies in the process of conducting environmental control trending and monitoring analysis.
• Capable to conduct scientific data gathering, analysis, interpretation and reporting of expert technical documents intended to diagnose the state of microbiological control of facilities and critical utilities (e.g. water for injection)
• Project Management Skills.
• Presentation Skills.
• Information/Computer Systems knowledgeable.
• Good interaction skills to enable appropriate performance supporting complex matrix organizations.

Description:
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.

SUMMARY
Perform one or more of the following duties and responsibilities in support of client’s Quality Assurance program under minimal supervision.

FUNCTIONS
– 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.

EDUCATION/LICENSES
– 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.

COMPETENCIES/SKILLS
– 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.