Analyst I, QC

Location
Baltimore (Bayview), MD, US
Posted
Sep 30, 2020
Ref
679450000
Discipline
Quality, Quality Control
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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
Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Collect environmental monitoring and utility samples of the facility.
• Perform various microbiological testing procedures of environmental monitoring and utility samples of the facility.
• Performs environmental monitoring during critical manufacturing operations.
• Perform plate reads and transfers as needed.
• Ability to perform aseptic technique and don aseptic gowning.
• Operation of an autoclave.
• Perform daily checks on equipment.
• Stock the lab on a daily basis.
• Cleaning the lab and equipment.
• Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
• Read and adhere to SOP's and Testing Standards as necessary.
• Review, analyze, interpret and report data.
• Verifies and enters approved results in laboratory information management systems (LIMS).
• Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
• Track time worked per project.

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

• BS or BA in Microbiology, Biological sciences, or related fields experience
• Ability to follow cGMP's and work in an FDA regulated environment
• Knowledge of microbiological methods
• Ability of sampling and testing of critical utilities and environmental monitoring within a GMP environment
• Conduct strict adherence to safety guidelines, proper documentation, and data integrity
• Must be able to gown as required in Production and QC Laboratory areas
• Strong aseptic technique experience
• LIMS (Laboratory Information Management System) experience is preferred, but not required.
• Knowledge and application of GMP principles, and working in an FDA regulated environment
• Strong communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
• Interpersonal skills: team building, consensus building, conflict resolution
• Critical analytical skills, strong verbal and communication skills
• Ability to work independently
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
• Excellent written and verbal communication skills

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.