Analyst III, LIMS (Baltimore (Bayview), MD, US, 21224)

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 position will be a subject matter expert in day-to-day admin functions for Lab Vantage, along with support quality control team as data coordinator and runners during FDA audits.

II: ESSENTIAL FUNCTIONS• Support transition from Sample Manager to Lab Vantage LIMS system

o Collect and validate data for master database creation (Lab Vantage)• Support, Maintain and administer Lab Vantage LIMS data base and other forms of electronic data at EMOB.

o collect and store data for pharmaceutical commercial operations

o act as runner to evaluate data requests, identify required data and present it in a audit ready format during regulatory/client audits• Maintain Lab Vantage LIMS modules to support QC testing, inventory management, raw material testing/release, cleaning validation and integration with other computerized site systems

o Conduct validation of LIMS subroutines, analyses and other code-based functionality

o Assist with writing and execution of test scripts• write/update LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation• Provides hands-on support to LIMS staff to provide support to end users:

o Assist users with issues, organize troubleshoot LIMS-related errors and coordinate with the IT team to assist with corrections, as needed.• Serve as the LIMS trainer/training coordinator overseeing the training of staff prior to the implementation of the computer system and offer advice and guidance on utilization of the LIMS application, as necessary.• Duties may include other support for instruments and related software that interact with the system• Primary responsibility is to perform administrative activities for the SampleManager® LIMS software and LABvantage. Including (but not limited to):

o User account information

o System configuration

o Change Request administration

o Report generation

o Data export

o Database management/validation

o System troubleshooting• Assist with sample delivery/receipt within the Quality Control Labs, as necessary• Assist with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols). • Author and collaborate on SOPs, Deviations, CAPAs, and Change Controls as necessary

o Ensure system is compliant with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments

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• Bachelor's degree in science, life science or IT from an accredited college or university or commensurate work experience in applicable fields.• 3+ years of experience within a cGMP/FDA/Biotechnological/Pharmaceutical environment. • Consideration will be given to candidates with a combination of education/training and relevant work experience with skills in computer/LIMS system and 21 CFR Part 11 compliance in a GMP/GLP regulated industry.• Experience working in or administering a LIMS application for a lab in the biological sciences, and strong knowledge on Empower • Strong written and oral communication skills • High level of motivation and independence• Basic skills and fluency in LIMS Systems, Adobe, Microsoft Word, Outlook, and Excel• Strong analytical, troubleshooting, and problem-solving abilities • Ability to work independently and in teams

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.