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I. JOB SUMMARY
Facilities Operations Specialist’s job purpose is to assess and implement system level improvements through the use of Quality Systems and Operational Systems. In addition, the Specialist’s role is to assist Facilities operations management or designee with various improvement initiatives as a Quality Systems SME.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
The Facilities Operations Specialist must have the ability to assess and implement system level improvements to the Emergent BioSolutions, Camden campus through the use of Quality Systems as well as be cross functional with project management and company accounting activities.
The Facilities Operations Specialist must be able to perform the following functions:
o Work with department employees on improving and updating preventative maintenance procedures.
o Complete, review, and route for closure engineering work requests in accordance with “Good Documentation Practices” to assure compliance with GMP.
o Ensure the performance of grounds related repairs and upkeep.
o Identify, and pursue, potential continued improvement activities.
o Work well with others, build and maintain positive employee relations.
o Will assist others in the Facilities & Maintenance department as needed.
o Demonstrated ability to perform routine work without instruction; requires general instructions on non-routine assignments.
o Deviations: Independently initiates and leads investigations of a wide variety of difficult and complex problems to determine root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future deviating events with the same root cause.
o CAPA System: Utilize this Quality system to evaluate identifiable factors to solve problems diverse in scope and implement continuous improvement corrective and preventive actions for system level improvements.
o Change Control System: Identify and initiate changes through collaborative efforts with Quality Assurance and applicable departments in
response to deviations, CAPA’s and departmental continuous improvement
o Utilizes multifunctional teams to implement process and continuous improvements within Quality Systems (Deviation, CAPA, CC, SOPs, etc.)
o Quality Metrics: Provide management with pertinent information regarding the state of all Facilities Operations quality systems and continuous improvement projects.
o Internal Audits: Respond to internal audit findings, including root cause analysis, identification of corrective and/or preventive actions (both global and specific).
o Performing SAP Trainings and Request access to all new employees for department.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelors degree or equivalent level of skill and experience, preferably in an applied science
• Experience with electronic document management, learning management, deviation, CAPA, and change control systems.
• 3-5 years in an FDA regulated industry.
• Expert understanding of regulations governing supported processes and systems.
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Ability to work independently and in a team setting with minimal supervision.
• Ability to make sound decisions regarding quality and compliance related issues with minimal supervision.
• Prior experience with SAP
• Strong project management skills
• Strong background in cGMP principles and concepts
• Proficiency in Microsoft Word and Excel
• Excellent organization and communication skills
• Should have experience / knowledge of Reliability / Predictive maintenance and Statistical Process Control
• Must have the ability to multi-task and coordinate workload by priority
• Must be customer-oriented and quality-driven
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.