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Analyst II, QC Microbiology & Sterility

Employer
Emergent BioSolutions
Location
Canton, MA
Start date
Apr 29, 2022

View more

Discipline
Quality, Quality Control, Science/R&D, Microbiology
Required Education
Bachelors Degree
Position Type
Full time

Job Details


 

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. 

ANALYST II, QC MICROBIOLOGY & STERILITY

 

Emergent BioSolutions is currently seeking an Analyst II for the QC Microbiology Department at our Canton location. The successful candidate will have a bachelor or master’s degree in an applied science, and 2-5 years of experience preferred. The ideal candidate will have hands on experience with one or more microbiology techniques, an understanding cGMP, CFR, USP and aseptic processing guidelines is required. Must have experience using MS Office and may be required to work weekends and nights.  In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

This is a laboratory testing position with the major responsibilities being daily testing, quality systems support, and inter-departmental scientific support.  Works on complex and varied problems/projects requiring in depth analysis and interpretation.

 

ESSENTIAL FUNCTIONS

 

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

Technical Expertise:

    • Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
    • Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.  Testing includes Sterility, Bioburden, endotoxin (gel clot), biological indicator testing. Environmental Monitoring, Utilities and Gas sampling and testing.
    • Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement, Microbial Limits testing, growth promotion.
    • Executes validation studies, obtain and interpret validation data following microbial guidance documents. Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs.

 

Laboratory Support (Including Quality Systems):

    • Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
    • Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory.
    • Uses GMP and scientific expertise to lead internal (department and site) audit activities.
    • Mentor and provide guidance to junior personnel.
    • Performs laboratory instrument calibration in accordance with established procedures.
    • Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate
    • Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
    • Ensure critical QC metrics are consistently met for product turnaround times.

 

Quality Systems:

    • Peer Reviews and Verification of QC data. Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports. Author laboratory investigations and non-conformance.
    • Supports CAPA and change control through participation in project planning and collaboration

 

Problem Solving:

    • Works on problems of diverse scope requiring evaluation of identifiable factors.
    • Exercises judgment within defined procedures and practices to determine appropriate action.
    • Receives minimal instruction on routine work, general instructions on new assignments.

 

Behavior/Cultural Responsibilities:

    • Ownership – Actively participate in self-development (IPMP)
    • Accountability – Follow through on commitments, Situational Leadership or additional accountability tools
    • Detail oriented – Able to complete required tasks and associated documentation with minimal error
    • Adaptability – Maintain positive attitude in a changing work environment
    • Communication – Effectively communicate with all levels of manufacturing and support staff
    • Actively participate in department / level meetings
    • Escalate issues through the proper channels
    • Live the Core Values

 

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.

 

SKILLS, EDUCATION & EXPERIENCE

  • Bachelor or Master Degree in an applied science (microbiology preferred).
  • 2 - 5 years of experience preferred, or equivalent level of skill and experience.
  • Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred.
  • Hands-on experience with one or more microbiology techniques: membrane filtration, inoculation (broth/agar), serial dilutions, biochemical tests, microbial identification, enumeration, environmental monitoring.
  • Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
  • An understanding of cGMP, CFR, USP, and aseptic processing guidelines is required.
  • Require good written and verbal communication skills, good team work skills
  • Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required.
  • May require work on weekends, and nights.

 

Interested? Please visit www.emergentbiosolutions.com to apply today!

 

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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.

Company

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Company info
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
United States

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