Analyst II, Quality Assurance

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
This role is responsible for assuring the quality of manufactured products, Packaging & Inspection
Operations support, CGMP compliance, Quality on the Floor continuous improvement, and client
satisfaction.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to
perform the essential functions.
• Perform product and labeling visual over-inspections
• Conduct GMP area In-Process, Logbook, and Walkthrough audits
• Complete Quality on the Floor batch record review
• Monitor key Packaging & Inspection processes
• Review and approve GMP records
• Participate in daily tier meetings with site partners
• Partner with Operations to meet schedule requirements and resolve challenges
• Support / assist timely closure of CAPAs, gap analyses, and product complaints
• Maintain company quality and safety standards
• Revise/review standard operating procedures (SOPs) and other controlled documents
• Support Packaging Quality on the Floor improvement initiatives
• Train new Pkg Quality on the Floor personnel on related procedures
• Support deviation and area investigations

This will be for 1st shift (6:00 a.m. – 2:30 p.m.) Monday thru Friday position. Overtime and
weekend work required, as needed, based on business needs.

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 relevant field with 0-2 years of GMP experience required; QA/QC role
preferred
• Ability to make sound compliance-related decisions with minimal supervision
• Must possess strong attention to detail.
• Ability to navigate computer programs such as Veeva (Document Management System)
and SAP (ERP System).
• Proficient knowledge of CGMP.
• Strong communication (written and verbal) and organizational skills.
• Ability to independently manage multiple priorities in a dynamic environment.
• High level of personal/departmental accountability and responsibility.
• Excellent teamwork and leadership skills.
• Proficient at resolving issues in creative and innovative ways.
• Exercises good judgment in selecting methods/techniques to achieve positive results.
• Understand and respond appropriately to a diverse population.

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.