Specialist I, QC Data Services

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I.    JOB SUMMARY 
The Quality Control Data Services Specialist will be responsible for supporting activities associated with the operational lifecycle of software and firmware-based instrument system applications within QC.

The Data Services group (DST) works with systems owners and business process owners (BPO) to provide data custodianship for Data Integrity (DI) through the design and operational lifecycle of software and firmware-based instrument system applications within QC.  The DST provides business unit, administrator-level support for the systems as required to accomplish data custodianship.  Responsibilities of the team include, but are not limited to, activities relating to system change control, DI assessments, IOPQ, CSV, training, administrator duties, deviations, and periodic review of audit trails and configuration specifications for systems.  

This position will coordinate the selection, procurement and commissioning of new systems and upgrades with QC senior management.  This position will not perform any GxP testing.   This position reports to the QC Manager of Data Services and is 100% on site.  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.

•    Serve as a task owner for CAPAs and CCRs for software and firmware-based equipment with Data Integrity (DI) impact to electronic data; including new software and software/firmware updates.  Assist with evaluation and selection of new equipment.
•    Work closely with QA, Validation, IT, and other functional business units and users to generate user requirements, data flow diagrams, and understand system functionality, as well as assist in implementation of new systems.
•    Author and revise equipment, software, and data service processes SOPs. 
•    Author and revise configuration specifications. Assist validation with software improvements identified during DI Assessments (drafting, reviewing, and executing qualification/validation protocols).
•    Organize and lead meetings related to DI projects and change controls.
•    Writes and reviews DI related deviations.
•    Assist with global/enterprise solutions, e.g., LIMS and Empower3.  Includes attending meetings and training as it pertains to the laboratory and completing project- or site-change control-oriented tasks with DI impact. 
•    Business unit administrator of local software and firmware applications, may assist with site-level administrator responsibilities for enterprise solutions. 
•    Conduct training sessions for new protocol and standard operating procedures, mentoring QC personnel to develop laboratory core competencies for operations and data integrity.
•    Performs periodic auditing or assessments of software and audit trails.
•    Assist with client or regulatory tours of the laboratories with respect to Data Integrity and as an SME on the software’s functionality and configuration.
•    Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
•    Support department compliance, Data Integrity, and capital spendings goals.
•    Participation in biomedical monitoring required.
•    Does not directly create, generate, acquire, etc. GxP data and is accountable for maintaining clear separation of role in all activities with respect to Data Integrity and administrative-level access on equipment.  

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 and Experience: A minimum of a B.S. in Chemistry, Biochemistry or related scientific discipline with a minimum of 7 years’ experience.   

Must have sound scientific background in analytical chemistry and/or microbiology and typical quality control applications.  Must demonstrate a knowledge and familiarity with broad range of software typically used in a GMP Quality Control environment.  Must have experience in and demonstrate broad knowledge in QC related validation and change control, including commissioning activities for laboratory equipment and software. Must have sound knowledge of IOPQ process and understand principals of validation.  Must have sound knowledge of current good Data Integrity practices and industry related expectations.  Must have experience in quality control change management.

Demonstrates knowledge and application of typical regulatory guidance such as cGMPs/GLPs, ICH, FDA, EMA, and CMC documents.   Demonstrates knowledge in Data Integrity principles.  Demonstrates knowledge of quality control regulatory requirements.  Expected to be familiar with CFR, USP, and EU regulatory requirements.  Demonstrates solid communication and presentation skills.  Demonstrates cross functional understanding and result-driven abilities. 

Must be highly organized, detail oriented, and able to manage multiple projects and work with cross-discipline personnel.  Must be capable of independent management of long-term projects.  Expected to make independent decisions for near-term goals.  Strong problem solving and root cause analysis skills.  Strong analytical and strategic thinking skills are expected.

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
 

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.