Specialist II, QA Data Integrity

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY 

The Quality Specialist II QA Compliance and Quality Systems is responsible for independent QA oversight of each Quality System as needed in support of commercial product manufacturing at the site and manages activities for one or more Quality System or cross-functional project. The Quality Specialist II QA Compliance and Quality Systems primary QMS focus will be SME of the CAPA system and Data integrity for the site. The Quality Specialist II will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance.  They apply expertise and regulatory knowledge to support change and risk management, and function as a QA SME for Data Integrity Assessments, Data Stream Mapping, Process Mapping, Remediation Design. 

ESSENTIAL FUNCTIONS

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

•    Owner of the site CAPA and Effectiveness check programs
•    QA owner and SME for Data Integrity Assessments, Data Stream Mapping, Process Mapping, Remediation Design, Report Creation.
•    Drive inspection readiness strategy and activities and serve as a subject matter expert in the CAPA quality system and Data Integrity. 
•    Represent the department in interactions with internal functional units and external contract partners or regulatory officials.
•    Critically review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
•    Support Internal audit program
•    Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
•    Prepare functional and Management Review metrics for identification of negative trends.  Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team  
•    Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s Degree in Scientific or related fields
•    A minimum of six (6) years of CGMP Quality experience in QMS 
•    Minimum of 1 year in DI initiatives
•    Strong Commercial manufacturing experience (Large Molecules) required
•    Quality Auditor, Six Sigma, or equivalent certification/education preferred
•    Experienced with US, ICH, EU and Canadian pharmaceutical regulations, ISO standards
•    Strong knowledge of Data Integrity principles. 
•    Expert Knowledge and application of GMP principles
•    Excellent communication skills: oral/written and listening
•    Excellent facilitation and presentation skills
•    Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching.
•    Interpersonal skills: team building, consensus building, conflict resolution 
•    Critical analytical skills, strong verbal and communication skills
•    Must be able to critically evaluate data summaries and conclusions
•    Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Chrome, Veeva, eLM, SAP, MS Teams, Access, and Visio.
•    Ability to influence without authority across cross-functional organization
•    Support Annual Product Review generation 
•    Background in QA IT is desirable

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.