Analyst II, Quality Control
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.
I. JOB SUMMARY
The QC Analyst II, position supports the Quality Control group at Emergent BioSolutions Rockville Campus. The role requires knowledge and understanding of scientific concepts, practices and procedures within the biopharmaceutical field and a cGMP environment. The role is responsible for daily routine testing and laboratory maintenance tasks such as Environmental Monitoring of the GMP area, and sampling and testing of water, compressed air, nitrogen and bioburden testing samples. Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Basic understanding of compliance/guidance/regulation pertaining to assigned are.
- Perform routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.
- Perform environmental monitoring during fill operations.
- Perform daily checks on equipment.
- Stock the lab on a regular basis.
- Inform Manager upon observing OOS, OOT, or deviations.
- Participate in investigations of OOS results and other related studies.
- Verifies and enter results in LIMS.
- Practice Good Documentation per the Standard Operating Procedures.
- Review record keeping and documentation of laboratory equipment maintenance.
- Support department compliance and productivity goals.
- Track time worked per project.
- Detailed oriented – Able to complete required tasks and associated documentation with minimal error.
- Adaptability – Maintain positive attitude in a changing work environment.
- Communication – Effectively communicates with all levels of manufacturing and support staff.
- Escalates issues through the proper channels.
Requires vaccination against different viruses including Vaccinia virus.
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
Education: BS in Microbiology/Biology or related field
Experience: 2-4 years in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.
Skills: Knowledge of MS Word, Excel and PowerPoint.
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.
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.