Senior Analyst, QC Data Services
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 Senior Analyst, QC Data Services leads and coordinates all Quality Control-business unit (BU) software/firmware change and risk management; including, but not limited to change controls, enterprise-level project deliverables, SOP writing, training design, risk management, and data integrity management. A primary focus of the position is supporting the introduction of an enterprise-wide LIMS into the QC Department, but the job scope extends to all business unit software/firmware applications. The Senior Analyst, QC Data Services reports to Quality Control Management. Typical hours are 8:00am – 4:30pm, Monday through Friday. Hours may vary to meet business and training needs.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• The SME and lead for BU activities for the introduction of a new enterprise-wide LIMS system into site’s BU processes. Functions include development of parameter lists for master data, UAT design/review, UAT execution, workflow design and implementation, and other global project deliverables. Works with Project Management, LIMS Administrator, and global LIMS project to accomplish tasks.
• The lead and coordinator of BU-related change for LIMS and other software systems. Duties include, but are not limited to, introduction and assessment of change design, review and execution of Design Testing/UAT, SOP writing, and training of users for change to workflows, reports, queries, interfaces, modules, etc. Works with Project Management, LIMS Administrator, and global LIMS project to accomplish tasks.
• The lead and coordinator of BU participation, communication, and risk/problem management for enterprise software solution projects such as LIMS or Empower3.
• Provide BU technical support for interfacing of BU equipment with LIMS or other software.
• Leads the design and implementation of BU LIMS training strategy and is the lead trainer for LIMS in coordination with the enterprise strategy; this includes design/optimization of reports and workflow and the standardization of training and execution of such.
• Lead BU participation in Data Integrity assessments and design/execution of remediation efforts.
• Serve as a technical expert to assist and provide support to end users for all business unit LIMS applications.
• Diagnose system problems and develop/coordinate resolution.
• Participate in BU group meetings and communicate updates to the group. Coordinate efforts of BU SMEs assisting with projects.
• Author and collaborate on SOPs, deviations, CAPAs, change controls, and investigations.
• The SME for the BU during client audit and regulatory inspections. Participation is required as needed.
• Supports compliance and continuous improvement in all functions. Writes technical documents as required.
• Contribute to the development of departmental budget and strategy and provide input on lab requirements and improvements.
• Organizes and leads meetings related to projects.
• Complies trend analysis and write associated reports for internal and regulatory use.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Track time worked per project.
• Participation in biomedical screening is required.
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: A minimum of a B.S. in Computer Science or related field is preferred. A B.S. in Life Science with commensurate experience will be considered.
Experience: Minimum of 3 years of experience in Pharmaceutical Industry supporting LIMS or equivalent Relational Database Management Systems (RDBMS) with a Master’s Degree or Ph.D., or 8 years with B.S degree. GLP/GMP experience is preferred. Experience with design, build, and/or support of LIMS or RDBMSs is preferred.
Knowledge: College and industry-level knowledge of Computer Science. Knowledge of relational database design and function required. Experience in adapting information systems and supporting software into business processes is required. Knowledge of Word and Excel required. Knowledge of cGMPs and regulatory requirements (21CFR Part 11) for electronic records.
Skills: Understands (RDBMS) design and interface with business processes. Uses knowledge of RDBMSs for technical troubleshooting and development/implementation of solutions for the business unit. Proficient in Word and Excel.
Abilities: Effective verbal and written communication, the ability to complete daily tasks as assigned, the ability to improve processes, the ability to work independently and in a group, the ability to multi-task, and the ability to train on and learn computer-based programs and systems. Proven demonstration of qualifications related to LIMS (or RDBMSs), Word, Excel, Word, systems is required.
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.