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 Systems is responsible for Quality oversight of processes occurring at the Camden and MDCW facilities which include management of quality systems (CAPA, deviations, complaints and change controls).
Supports internal and external Quality Systems, such as facility/equipment, materials, production, laboratory, packaging/labeling, final drug product review.  Supports internal and external customers.  Assure compliance with current GMPs.

II.    ESSENTIAL FUNCTIONS

•    Supports the Quality Systems department in various tasks associated with eQMS processes which at Emergent is Veeva Vault. 
•    Critically reviews complex records (e.g., CAPA Plans, deviation investigations, etc.) to ensure completeness, accuracy and compliance.
•    Serves in a decision-making capacity on major document changes, deviations, corrective and preventive actions and other projects.
•    Exercises judgment within defined procedures to determine appropriate action for resolution of quality issues.
•    Writes moderately complex technical documents.
•    Assists in the maintenance of quality plans, including tracking and advancing initiatives, routinely reporting progress, and maintaining documentation as it relates to Quality Systems. 
•    Compiles and reports performance metrics for deviations, CAPAs and other relevant Quality Systems activities.
•    Revises Standard Operating Procedures and forms, as needed. 
•    Demonstrates strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
•    Resolves a wide range of issues in creative ways.  Defines appropriate actions and requirements for resolution of issues.
•    Provides logistical support and technical knowledge during regulatory and internal inspections of Emergent quality systems.
•    Communicates effectively with management project status, issues and mitigations
•    Maintains company quality and safety standards. 

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

•    BS degree in Chemistry/Biology or related discipline with > 5 years GMP experience required
•    Proficient knowledge of cGMP, minimum of 5 years in an FDA regulated industry.
•    Ability to make sound decisions regarding compliance-related issues with moderate supervision.
•    Must have strong attention to detail.
•    Ability to manage multiple priorities and tasks in a dynamic environment.
•    Strong communication skills (written and verbal) and strong organizational skills. 
•    High level of personal/departmental accountability and responsibility.
•    Ability to exercise judgment to determine appropriate corrective actions.
•    Ability to use computer programs such as Access, Excel, SAP and an electronic document management system.
•    Ability to work in a team environment and to work within that team to maximize efficiency and throughput.

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.