Analyst II, QA Compliance

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I. JOB SUMMARY
The Analyst II, Quality Compliance role is responsible for participating in activities that positively impact the overall Compliance health of the Camden site through Internal Audits and Inspection Readiness (preparation and logistics). This position also supports continuous improvement of the Quality Management System in place at the Emergent BioSolutions Camden site.

Responsible for supporting internal and customer audits, and regulatory inspections. This position will manage the supporting activities relating to internal and customer audits.

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

General Compliance

* Support the development and maintenance of internal audit schedules for the upcoming year based upon site activities, system performance, and known opportunities for improvement.

* Write and distribute audit plans, checklists, reports and communicate audit results to audited areas.

* Plan, schedule and conduct internal audits per audit schedule with no management oversight. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan.

* Gather and analyze information from a variety of sources, including documents, records, observations, and face to face personnel interviews to understand processes and assess compliance to GxP regulations, as well as opportunities for improvement in effectiveness and efficiency of site processes. Strong judgment, critical analysis, critical thinking skills required.

* Follow up with Area Management on audit responses and corrective actions. Provide support as needed to clarify root cause analysis and identify appropriate corrective action plans that are global in nature (when applicable).

* Partner with Area Management to discuss findings, drive to consensus on resolution and corrective actions. Effectively negotiate difficult conversations on a routine basis.

* Administer CAPAs that result from Internal Audit activities, ensuring all actions are implemented according to CAPA Plans and assessing the effectiveness of those actions in accordance with regulatory expectations.

* Collect tracking and trending information, analyze trends, root causes of unfavorable performance, and necessary adjustments to ensure the system is operating as required.

* Reporting metrics to the Management Review program, including reporting to Senior Management as necessary. Collaborate with Senior Management to verify decisions and actions made during Management Review.

* Support preparation activities in advance of and during regulatory audits (announced or unannounced), including but not limited to maintaining documentation demonstrating prior commitments were met, following-up on areas of potential vulnerability and communicating / mitigating accordingly, and coordinating the logistical matters of hosting an audit / inspection.

* Actively participate in regulatory audits / inspections as a Lead Escort or Lead Document Review and Preparation Coordinator (as needed). Strong technical judgment, professional presence and advanced communication skills required.

* Support response activities following external audits / inspections, working with teams to identify root causes and feasible corrective / preventive action plans.

* Oversight and management of the department's SharePoint page; strategically implement ideas, information in an organized and simplistic flow for end users and internal customers.

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 management's 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 science or related degree
* Certified Quality Auditor certification within one year of hire
* Prior experience with US and EU pharmaceutical regulations, ISO standards
* Strong knowledge and application of GMP principles and working in an FDA regulated environment.
* 2-5 years prior experience conducting quality audits and can operate without direction on the general and additional responsibilities.
* Must be able to independently multi-task in a fast-paced environment, deciphering the mundane routine tasks from the critical tasks that require immediate attention.
* Critical analytical skills required for audit planning, analysis of activities, procedures and documents and report writing. Also required for Management Review reporting. 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.
* Strong ability to decipher key audit processes from routine, utilizing a risk-based approach to target audits on critical activities.
* Ability to work independently in conducting internal audits.
* 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.
* Ability to work under pressure and analyze processes within scheduled timeframes.
* Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, Visio, SAP, and LMS
* Able to analyze a large volume of industry information (journals, magazines, compliance articles) and assess for criticality and application.
* Excellent presentation skills

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 .

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.