Analyst III, Quality Control

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

Perform analytical testing per cGMP in support of raw material, in-process, final product, stability and method transfer testing.

Typical hours are 8:30AM-5:00PM. Hours may vary to meet business and training needs.

II: Essential Functions

• Perform various analytical testing procedures as per manufacturing/Quality Control batch records, stability protocols, etc.
• Executes complex methods requiring difficult sample preparation or data analysis.
• Assist with design of method validations, executes validation studies including method transfer activities.
• Work with Project Managers and QA to ensure timely testing and release of samples.
• Perform instrumental analysis such as Karl Fischer, HPLC, and Gas chromatography.
• Inform QC management upon observing out of specification results.
• Participate in investigations of OOS results and other related studies.
• Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
• Write protocols and reports as necessary.
• Plan and execute experimental tasks, obtain and interpret experimental data with minimal guidance.
• Perform review of calculations, logbooks and other data to execute LIMS approval, lot release protocol and final product data authorizations or approvals.
• Write and review SOP's and Testing Standards as necessary.
• Interact with clients as necessary regarding CGMP, tech transfer methods, or stability issues
• Assist in training other Analysts.
• Review, analyze, interpret and report data.
• Verifies and enters approved results in LIMS.
• Develop and execute validation scripts as needed for change control implementation.
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Support department compliance and productivity goals.
• Track time worked per project.
• Participate in meetings as required.

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

III: Minimum Education, Experience & Skills

• B.S. in Chemistry or related field
• 3-5 years in a GMP chemistry laboratory in the pharmaceutical environment with method development experience
• LIMS and Empower experience are a must. Knowledge of Agilent/Waters instruments is a must.
• Experience with non-conformance, CAPA, and change control systems.
• Strong initiative, organization ability to work independently
• Capable to lead and/or participate with multidisciplinary within the site or within the organization
• Proficiency in MS Office products or comparable word-processing and spreadsheet applications is required.  

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.