Analyst I, Quality Control, Microbiology
6 Months
Norwood, MA
Hourly Pay: $38.48
Shift: Tuesday - Saturday, 10am-6pm
NOTES:
- Bioburden/endotoxin/environmental monitoring experience required.
- 0.5 - 2 yrs exp required
- Lab investigations & culture purity experience preferred but not required
Job Summary
In this role, you will support cGMP microbiology methods for QC raw material, plasmid, drug substance, Stability and finished product testing for mRNA products produced at manufacturing facility. This individual will contribute to non-testing projects and activities as needed example document certification, monthly biosafety cabinet cleaning etc.
Job Responsibilities
- Execute compendial microbiological testing, and other methodologies as needed.
- Receive Environmental Monitoring Plates into MODA, Incubate, Microbial identification,
- Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
- Assist in enumeration of test plates, review EM data, etc.
- Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs, Document Certification, archival etc.
- Stock and perform inventory of lab supplies.
- Establish and maintain a safe laboratory working environment.
- Additional duties as may be assigned from time to time
Education & Qualifications
- BS in a relevant scientific discipline with a minimum of 0 - 2 years (or MS in a relevant scientific discipline with 1 year) Quality Control experience in a cGMP organization
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software)
- Strong written and oral communication skills as well as organizational skills
- Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.