Analyst II, Quality Assurance

 Preparedness today, safer tomorrow.

 Emergent is a leading public health company that delivers protective and life-saving solutions to
 communities around the world.  Here, you will join passionate professionals where our culture is informed
 by our values and commitment to protecting and saving lives.

JOB SUMMARY 

The Analyst II, Quality Assurance position is a quality professional responsible for QA oversight of manufacturing/production processes and Quality Control laboratories. Responsible for QA oversight of production process, and the execution of routine Quality System work on the manufacturing floor. The Analyst II also serves as a subject matter expert in Emergent QA routine operations and may represent Emergent during on-site inspections. This position frequently interacts with team leads, supervisors, and other cross functional peers. 

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

Manufacturing Support  

• Provide direct quality “on the floor” support and oversight, troubleshoots basic issues with supervisor support.
• Follows written instructions in the routine review of laboratory and production records in accordance with Emergent standard operating procedures and good documentation practices (GDP) and principles of data integrity.
• Perform label control processes such as counting, verification, issuance, receipt and reconciliation of components.
• Coordinates with other Quality Assurance team members to ensure adequate support of manufacturing operations.
• Assist with Procedure Reviews and Product Dispositions, Release intermediate and raw materials for further processing.
• Reviews routine work orders, return to service, and other documentation to ensure that equipment and utilities are fit for use.
• Act as a support/backup Quality Assurance subject matter expert for an integrated process team.
   
  Quality Systems  
• Provide input to authors and task owners for document revisions, deviation investigations, CAPAs, and change controls related to Document Control processes
• Supports minor and mid-level deviation investigations, which may contain root cause analysis and corrective actions. 
   
  Document Control  
• Ensure documents meet established formatting standards
• Manage implementation activities of documents, including lifecycle states in the Document Management System, user notifications, and issuance & reconciliation of controlled copies
• Complete record activities including issuing, reconciling, scanning, and archiving
• Troubleshoot and provide support for internal customers with technical questions related to Document Control processes and IT applications
• Participate in routine audits of Document Control processes and provide recommendations for improvement 
   
  Continuous Improvement 
• Identify opportunities for improvement within scope of work
• Participating in department organization and 6S activities 
   
  Regulatory Inspections 
• Provide campus support during internal audits and regulatory inspections of Emergent quality systems, serve as a subject matter expert to support regulatory interviews on routine quality assurance tasks.
• Participate on response teams to address observations and recommendations made during internal audits and inspections 

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. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BA/BS (in an applied science preferred) or equivalent work experience.
• 2-5 years of experience working in a regulated industry.
• Experience with quality assurance preferred.
• Experience with aseptic processes preferred, BSL-2 and BSL-3 preferred.
• Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills.
• Ability to make sound decisions regarding moderately complex compliance-related issues with supervision support.
• Must exhibit Personal/departmental accountability.
• General Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP).

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $61,000 to $73,900. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data.  The salary may also be adjusted based on applicant’s geographic location.  Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*.  Information regarding additional benefits can be found here:  https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

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.