Specialist I, Data Integrity
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 Data Integrity Specialist will be responsible for assisting the Camden facility in determining systems that are impacted by data integrity requirements. The position requires thorough understanding of data integrity and 21 CFR Part 11 requirements. Role requires working with cross functional teams to identify computerized needs for new systems, upgrading systems and decommissioning to ensure proper equipment is used and compliant. The position requires strong technical knowledge of computerized laboratory and enterprise systems, GAMP processes, and risk management. A good understanding of the computer system validation to the software development life cycle is necessary.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Project Manage data integrity activities and cross-functional team meetings.
• Manage a master list of systems for data integrity assessments.
• Supports efforts for conducting risk assessments (i.e., risk, rank, filter, questionnaires, etc.) to establish risk levels.
• Coordinate and create data flow process models and system configuration documents for each system determined to have significant data integrity risk based upon results of the system risk assessment.
• Author documents such as procedures, summary report, and status reports related to the data integrity project as required.
• Plan, organize, and conduct regular meetings with sub-teams to ensure timely completion of data integrity deliverables.
• Track project and deliverable status and provide require project and deliverable status updates to Quality Assurance management.
• Provide input to overall data integrity project plan.
• Function as system administrator for defined computerized systems
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 required; will consider a combination of education/training and relevant work experience with skills in computer system validation, GAMP, Data Integrity, and 21 CFR Part 11 in a GMP regulated industry.
• Minimum 5 years related experience and 7 years in pharmaceutical industry with relevant understanding of laboratory operations.
• Basic skills and fluency in Microsoft Word, Outlook, and Excel
• Experience with laboratory instrumentation/equipment and control systems used in GMP and/or GLP environment
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.