Associate Specialist, Facility Operations
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
Facilities Operations Associate Specialist’s job purpose is to assess and implement system level improvements with Quality Systems and Operational Systems. In addition, the Associate 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 Facility Operations Associate Specialist must have the ability to assess and implement system level improvements to the Emergent BioSolutions, Camden campus with Quality Systems.
• The Facilities Operations Associate Specialist must be able to perform the following
o Oversee various service contractors at Camden campus.
o Work with department employees on improving and updating preventative
o Complete, review, and route for closure engineering work requests in
accordance with “Good Documentation Practices” to assure compliance with GMP.
o Assist in authoring change controls as directed.
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.
CAPA(Corrective and Preventative Actions) Management for Department:
o Department deliverable management for deviation CAPA actions
o Manage process improvement CAPAs for the department
o Utilizes multifunctional teams to implement process and continuous improvements at the site
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, and identification of corrective and/or preventive actions.
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
• Bachelor’s degree preferred or equivalent related experience
o 2 -4 years related experience in a highly-regulated industry/environment
• Prior experience with SAP Skills
Experience with Quality Systems required
strong preference for Veeva Quality Systems
• 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
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.