Analyst III, 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 III, 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. T Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments. In this role, Individuals will use soft skills, to work on QC schedules and to work with internal customers (EHS, Manufacturing and QA). People leader skills will be cultivated in this role.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Assist the Manager, QC Micro / Analytical with feasibility assessment of client projects
- Perform microbiological / analytical work per method transfer/ validation programs.
- Perform environmental monitoring and utility testing of the facility.
- Performs environmental monitoring during fill operations (as necessary)
- Write method validation / transfer protocols and reports as necessary.
- Perform various microbiological / analytical testing procedures per Quality Control batch records and stability protocols.
- Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
- Participate in investigations of OOS results and other related studies.Assist with complex investigations by obtaining root cause and implementing changes.
- Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues.
- Write, review, and revise SOP’s and Testing Standards as necessary.
- Train additional employees in methods, transfers and techniques
- Review, analyze, interpret and report data.
- Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
- Resource for technical knowledge of current assays
- Uses analytical and statistical concepts to understand variable sin assays
- Assess the compliance status of current test methods and equipment
- Applies analytical knowledge to support change and risk management
- Review record keeping and documentation of laboratory equipment maintenance.
- Work with Project Managers and QA to ensure timely review and approval of protocols /reports.
- Support department compliance and productivity goals.
- Participate in meetings as required.
- Track time worked per project.
- Interview and recommend the employment of technical and professional supporting staff.
- Identify and implement continuous improvement opportunities to reduce non-value added work or complexity.
- May require work on weekends and nights, travel, or work with 3rd party vendors.
- 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.
- Actively participate in department level meetings.
- Escalates issues through the proper channels.
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
Education: BS in Microbiology/Biology or related field
Experience: 3-5 years (MS with 3+ years) in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes. Track record of achievement and sustained performance in a cGMP/GLP environment. Strong technical and communication skills: oral/written and listening. Personal Competencies: Self – awareness, Integrity, Team Player, Creative and Flexible
Skills: Knowledge of MS Word, Excel and PowerPoint.
Requires vaccination against different viruses including Vaccinia virus.
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.