Analyst I, QC Environmental Monitoring
- Emergent BioSolutions
- Lansing, MI
- Start date
- Mar 17, 2023
- Clinical, Clinical Testing/Monitoring, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
This is a laboratory testing position with the major responsibilities being daily collection and testing of routine water and facility samples as well as laboratory maintenance. Additional responsibilities involving support of Quality Systems may be required.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Technical Knowledge or Expertise
• A basic understanding of compliance/guidance/regulations including cGMP, CFR, USP, and aseptic processing
• Performs routine testing following written procedures
General Environmental Monitoring Responsibilities
• Maintains the lab and associated areas using the LEAN 5S concept
• Transfer and disposal of biohazard waste and chemicals
• Use of the Laboratory Information Management System (LIMS) for data entry, sample collection, and testing
• Review and filing of completed raw data
• Initiation of work notifications, and performance of routine maintenance activities
• Uses and Maintains a BSC
• Uses an Autoclave
• Obtains gowning certification
• Demonstrates technical knowledge to perform basic laboratory tests including, but not limited to:
- Examination of viable samples for microbial growth
- Total Microbial Count Testing
- Bacterial Endotoxin Testing
- Conductivity Testing
- Biological Indicators
- Visual Inspection
• Competently performs routine collection and documentation of samples including, but not limited to:
- Critical utilities systems (Clean-steam, Water systems, and gas delivery systems)
- Viable and non-viable samples within the Emergent manufacturing suites while using aseptic techniques
• Identifies and supports change and continuous improvement using LEAN practices such as 5S and Kaizen.
• Works on problems of simple to moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Exercises judgement within defined procedures and practices to determine appropriate action.
• Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Receives general instructions on routine work, detailed instructions on new assignments.
• Ownership – Actively participate in self-development
• Accountability – Follow through on commitments
• 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 meetings
• Escalate issues through the proper channels
• Demonstrates and upholds Emergent’s 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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s degree in an applied science with 0-2 years of experience, or equivalent related experience in cGMP biologics/pharmaceutical Quality Control
• Proficiency in MS Office products or comparable word-processing and spreadsheet applications is required.
• Previous experience with analytical or microbiology techniques in a GMP manufacturing environment is preferred.
• An understanding of cGMP, CFR, USP, and aseptic processing guidelines is preferred.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.
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
400 Professional Drive
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