Specialist II, QA
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
The Quality Assurance, Specialist II will provide QA oversight and support of quality systems in support of commercial product manufacturing at the site and managed activities for one or more quality system or cross-functional project.
The Quality Assurance, Specialist II will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems, and plant compliance. This role will also apply expertise and regulatory knowledge to support change and risk management, as well as lead/assist in hosting audits/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:
- Change Controls
- Data Integrity / Data Governance
- Risk Management
- 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
- 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
- Represent the Quality Systems department in a review and decision-making capacity on site projects
- 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
- 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
- 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
Inspections / Audits
- Lead logistical support and technical knowledge during internal audits and external 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
* May require vaccination against various viral products, including the Vaccinia virus.
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, preferably in an applied science
- American Society for Quality (ASQ) certification (preferred)
- 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
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.