Analyst II, QC Data Services at Emergent Biosolutions in Lansing, Michigan

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY

This position assists the Quality Control (QC) department processing and authorization of QC data. Additionally, the position includes the general oversight of EM data specifically the acceptance of aseptic and critical utility processes.

ESSENTIAL FUNCTIONS

*Create, print, and assemble QC paperwork required for Environmental Monitoring of the facility, Manufacturing operations, and critical utility systems.

*Enter, verify, and approve QC results in LIMS and on raw data sheets.

*Coordinate correction of errors discovered on QC raw data sheets with associated departments.

*Prepare reports and memos required for release of materials or systems for use (for example, sublots, batches, final filled lots, intermediates, media qualifications, and spore suspensions).

*Track approval of QC paperwork to ensure delivery to Quality Assurance for final review by need-by dates.

*Reconcile, file, and maintain completed QC raw data sheets and associated paperwork according to the company records retention policy.

*Review logs for completion and good documentation practices.

*Track and order QC sampling and office supplies.

*Perform the following LIMS functions:

• Audit QC data to ensure timely completion and approval; follow-up with necessary personnel to ensure outstanding issues are completed.


• Manage requests for the LIMS change request process.

*This position may require work on weekends and nights.

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

*High School Diploma required.

*Minimum 4-6 years of related experience.

*Understanding of standard concepts, practices, and procedures within a cGMP environment required.

*Data processing experience, strong typing, and communication skills required.

*Previous experience with MS Office products (Word, Excel, PowerPoint, and Outlook) and database entry is desired.

*Uses sound judgment to resolve problems and make routine decisions.

*Has the ability to work independently on routine work.

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.