Specialist I, Quality Systems

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

Provides oversight and support of quality systems using company procedures and regulations. Conduct system and process training. Analyze business processes and recommend best practices. Provide support during internal audits and regulatory inspections.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Quality System Support

• Serve as process owner for at least one quality system:
  • Act as process subject matter expert with detailed knowledge of process history, compliance, operations, changes, and deviating events
  • Monitor performance metrics, including identification of trends that require preventive action and cross-functional collaboration to determine the root cause of process performance issues, and taking the necessary action to improve performance
  • Present objective data regarding process performance to Functional Area and Senior Management
  • Maintain up-to-date knowledge of industry and regulatory trends to ensure system remains compliant with stated expectations and best practices
• Author and execute tasks for deviation investigations, CAPAs, change controls, and document revisions
• Process access requests, perform user analysis, and make recommendations for relevant computer systems for supported quality systems
• Develop, schedule, and conduct site training for supported quality systems, assess effectiveness of training following completion
• Serve as the Quality Assurance role for supported quality systems
• Represent the Quality Systems department in a review and decision-making capacity on site projects and global initiatives
• Coordinate work across systems, functions, and sites to harmonize workflow, clearly identify responsibilities, and optimise cross-functional team member participation
• Network with counterparts at other sites to leverage and implement best practices
• Perform gap analyses to identify training needs and work cross-functionally to reduce deviating events attributable to human error for supported quality systems
• Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding
• Assist in the development of procedures and other documents to accurately reflect work practices, including application of documentation format, structure, and hierarchy standards
• Actively apply quality tools and training to ensure the best possible outcome of quality improvement efforts

Continuous Improvement

• Identify opportunities for improvement within scope of work
• Maintain documentation of quality improvement efforts that is suitable for presentation to site leadership and during audits & regulatory inspections
• Coordinate and lead department improvement activities (i.e., 6S, PDSA cycles)
• Develop training materials and educate department personnel on lean concepts
• Perform process assessments to ensure effectiveness of site and/or global deployments

Regulatory Inspections

• Lead logistical support and technical knowledge during internal audits and regulatory inspections of Emergent quality systems, including interacting directly with audit and regulatory personnel to discuss areas of expertise
• Lead on response teams to address observations and recommendations made during internal audits and inspections

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

Education

• Bachelor's degree, preferably in an applied science
• American Society for Quality (ASQ) Quality Auditor, Process Analyst, Lean, or Manager of Quality/Organizational Excellence certification (preferred)

Experience

• Minimum of 5 years related experience
• Minimum of 5 years in an FDA regulated industry
• High understanding of deviation investigation, root cause analysis, CAPA, and change control systems
• Expert understanding of regulations governing supported processes and systems
• Strong computer skills with the Microsoft Office product line
• Strong leadership skills; high level of personal/departmental accountability and responsibility
• Ability to work individually and in a team environment with minimal supervision
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations
• Ability to make sound decisions regarding quality and compliance related issues
• Ability to lead small groups of employees to accomplish common goals

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.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

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.