Title: QC EM/Microbiology Specialist (4 Openings)
Shift: 9AM-5PM - Sunday-Thursday - 5 days a week on-site
Location: 316 Northern Ave - Boston, MA
Open: 4
Pay Range: $33-45/hr
Start date: ASAP
Must-Haves
- 2+ years of experience in a pharmaceutical, biotech or laboratory setting (microbiology and environmental monitoring preferred).
- Previous experience in a GMP environment and a strong understanding of GMP concepts / best practices.
- Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection
- Ability to work off-shift hours as needed
- Bachelor's degree in microbiology or related field
Plusses
- Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results
Responsibilities
- Perform cGMP analytical and microbiological data review for various techniques such as HPLC, GC, KF, TOC, Bioburden, endotoxin, TOC, Environmental monitoring, IR and dissolution to ensure adherence to established methodology, procedures and SOPs
- Assisting with maintenance and calibration activities
- Review laboratory instrument qualification and requalification packages executed by vendors
- Review laboratory equipment logbooks
- Provide support and oversight of laboratory equipment PM/calibration program to ensure on-time completion
- Ensure all laboratory records are accurate and adhere to cGMP/GDP expectation
Day-to-Day
Insight Global is looking for a Quality Control Scientific Associate to sit on site in Boston, MA at a large global pharmaceutical company. The position will be on-site in the beautiful Seaport district, for a Sunday through Thursday, first shift schedule. This role will provide a variety of analytical functions that occur in the QC environmental monitoring and utilities monitoring laboratory. The individuals will perform hands-on environmental monitoring and utilities sampling, testing, and reporting, supporting oral dose and cell therapy GMP manufacturing facilities.
A successful candidate for this role will have multiple years of experience in a GMP laboratory setting, preferably in microbiology or environmental monitoring. Additionally, they should have a strong understanding of US and EU cGMP regulations. Finally, they must have some flexibility to work off hours if necessary. This is great opportunity for a quality control associate to take on more responsibility!
Job Type: Contract
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- Microbiology: 2 years (Required)
- Environmental Monitoring: 1 year (Required)
- Quality control: 2 years (Required)
Ability to Commute:
Ability to Relocate:
- Boston, MA: Relocate before starting work (Required)
Work Location: In person