Specialist, EFVQ Systems

Emergent Biosolutions•Lansing, MI

12d

About The Position

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.JOB SUMMARY The Specialist, EFV Quality Systems provides quality systems knowledge and support to ensure departmental compliance. Responsible to assess and implement system level improvements and deliver on site quality objectives. Provide support to the other sites and global EFV initiatives as needed. ESSENTIAL FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Proposes unique solutions to problems of a diverse scope using technical proficiency, creativity, and collaboration with others through independent thought, communication, and technical writing. Demonstrates good judgement in selecting methods and techniques for resolving issues and obtaining solutions with minimal input from leader. Accountable for all EFV Quality System functions including: Deviations: the ability to initiate, investigate root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future deviating events with the same or similar root cause(s). CAPA System: the ability to utilize this Quality System to identify and implement continuous improvement corrective and preventive actions for system level improvements. Change Control System: the ability to identify and initiate changes through collaborative efforts with Quality Assurance and various departments in response to deviations, CAPA’s and departmental continuous improvement projects. Procedure Revisions: the ability to create new procedures and revise existing procedures including Preventive Maintenance, Calibration, as well as performing Biennial reviews of existing procedures. Audit Responses: the ability to investigate through root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future internal and external audit observations with the same or similar root cause(s). Quality Metrics: monitor due dates and ensure timelines are maintained for all EFV quality related deadlines. Participates in regulatory agency inspections as required. (CDC, FDA, Health Canada, etc.) Trains and provides technical support as an SME to support operations and EFV initiatives. Prepares documents, reports and presentations with the ability to lead effective meetings. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Requirements

BS in Engineering, Science, Management, or equivalent experience.
A minimum of 5 years of experience in a biopharmaceutical or related environment in an engineering or quality role, at least 3 years working in EFV support functions.
Expertise in quality management system approaches, documentation, and requirements.
Should have experience/knowledge of reliability/predictive maintenance and Statistical Process Control and the entire equipment lifecycle.
Good understanding of GMP, data integrity requirements, and ability to work with teams to develop effective and lean solutions
Strong track record of partnering with end users and quality, as well as external inspection agencies to improve our systems and processes and produce high quality documentation.
Project management skills are essential
Exceptional communications skills with all levels of the organization

Responsibilities

Proposes unique solutions to problems of a diverse scope using technical proficiency, creativity, and collaboration with others through independent thought, communication, and technical writing.
Demonstrates good judgement in selecting methods and techniques for resolving issues and obtaining solutions with minimal input from leader.
Accountable for all EFV Quality System functions including:
Deviations: the ability to initiate, investigate root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future deviating events with the same or similar root cause(s).
CAPA System: the ability to utilize this Quality System to identify and implement continuous improvement corrective and preventive actions for system level improvements.
Change Control System: the ability to identify and initiate changes through collaborative efforts with Quality Assurance and various departments in response to deviations, CAPA’s and departmental continuous improvement projects.
Procedure Revisions: the ability to create new procedures and revise existing procedures including Preventive Maintenance, Calibration, as well as performing Biennial reviews of existing procedures.
Audit Responses: the ability to investigate through root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future internal and external audit observations with the same or similar root cause(s).
Quality Metrics: monitor due dates and ensure timelines are maintained for all EFV quality related deadlines.
Participates in regulatory agency inspections as required. (CDC, FDA, Health Canada, etc.)
Trains and provides technical support as an SME to support operations and EFV initiatives.
Prepares documents, reports and presentations with the ability to lead effective meetings.