Analyst III, QA Compliance

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.

I.    JOB SUMMARY 
The Analyst III, Quality Compliance is responsible for supporting Emergent in all aspects of regulatory inspections, internal and customer audits; including co-hosting and coordinating audits, inspection preparation and logistics; as well as preparing written responses, ensuring completion of all audit-related corrective actions.

Responsible for conducting Internal Audits, managing responses and CAPA’s. This position is responsible for CGxP compliance (and all other applicable regulations) and supporting activities relating to these systems at the Camden site.

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

General Compliance 
•    Maintain an understanding of current industry regulations, guidelines, and standards as well as regulatory activity and current trends in 483’s, warning letters or other recent regulatory actions.
•    Support Quality Assurance and Emergent during FDA, EU, Health Canada, and other regulatory agency inspections and customer relation activities with CDC, BARDA, etc.
•    Compile inspection response reports, gather monthly response updates and coordinate response owner teams.

General Quality Systems:
•    Serve as reviewer and approver of documents ensuring data integrity and traceability, clarity of technical writing, compliance with SOP’s/regulations and suitability for review by regulatory authorities.
•    Define, prepare, and communicate metrics, trends, and data summaries to management as needed.
•    Work across all disciplines and functional areas to ensure that the site maintains a state of inspection readiness. 
•    Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as appropriate.

The following activities are focus areas, that may be a primary or a secondary responsibility:
Internal Audit Coordination:
•    Develop internal and (possibly external) audit schedules for upcoming year. Write and distribute audit plans and reports. Conduct Internal and external audits (as applicable), according to the established schedule, with minimal oversight. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan.
•    Communicate audit results to audited areas and Management.
•    Analyze multiple documents, records, and findings, as well as interview personnel, to determine compliance to CGxP regulations.  Strong judgment, critical analysis, critical thinking skills required.  
•    Must be able to multi-task, self-manage your time, consolidate, and analyze multiple documents simultaneously.
•    Follow up with area management on audit responses and corrective actions.  Provide support as needed to clarify root cause analysis and appropriate corrective actions.
•    Responsible for system effectiveness, propose and implement continuous improvements and provide system trending information.

Regulatory Inspection Coordination:
•    As the Co-Host and coordinator for Regulatory inspections- support day to day inspection activities, communicate status/findings and coordinate all necessary resources, throughout the inspection.
•    Analyze multiple documents, records, and findings, as well as interview personnel, to determine compliance to CGxP regulations.  Strong judgment, critical analysis, critical thinking skills required.  
•    Follow up with area management on inspection responses and corrective actions.  Provide support as needed to clarify root cause analysis and appropriate corrective actions.
•    Effectively negotiate difficult conversations on a routine basis.
•    Verify corrective action effectiveness in accordance with regulatory expectations.

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 in Biological Science or similar scientific field
•    Minimum of 5 years of parenteral pharmaceutical cGMP Quality experience with increasing responsibilities 
•    Prior experience conducting quality audits and can operate without direction on the general and additional responsibilities.
•    Previous experience working with FDA (CBER) and participating in regulatory agency inspections desired.
•    Must have a full understanding and knowledge of cGMPs and EU Regulations.  
•    Critical analytical skills required for audit planning, analysis of activities, procedures and documents and report writing. Critical analysis applies to understanding the integration of quality system activities and connectivity to continual improvement activities. 
•    Advanced communication, verbal and written skills negotiation and conflict management skills required for audit management.  Must be able to present a diverse set of concepts into a clear, concise written and oral format.
•    Ability to decipher key audit processes from routine, utilizing a risk-based approach to target audits on critical activities.
•    Must be able to independently structure meetings, create agendas and well-developed minutes with documented decisions and actions to ensure thorough and timely understanding by impacted parties.
•    Must have Change Control, SOP, investigation, and protocol writing skills and demonstrated ability to critically evaluate content and criticality of information.
•    Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for internal and external review.  
•    Proficiency in MS Office products, SAP or comparable word-processing and spreadsheet skills are required.

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.