Analyst I, QC Microbiology
Emergent BioSolutions
3 days ago
On-site
Lansing, MI
Operations
Job Summary
- Perform daily laboratory testing and sample collection per approved procedures, specifications, and regulatory requirements.
- Conduct sample preparation, execute test methods, accurately document results, and report data timely.
- Ensure testing follows attention to detail, data integrity, and safety standards.
- Support laboratory maintenance: clean/basic equipment maintenance, inventory management, waste disposal, and maintain inspection-ready workspaces.
Essential Functions
- Technical expertise: understand compliance/guidance/regulations for assigned area; perform routine testing/sample collection with supervisory oversight for limited non-routine/validation studies.
- Perform microbiology/bioassay testing (e.g., purity/filtrate/enumeration, aseptic technique; animal injections preferred—SubQ or ID).
- Laboratory support/quality systems: continuous improvement using LEAN (6S+, Kaizen); perform initial review; enter passing results in LIMS; receive/label/restock reagents and supplies; maintain equipment.
- Support GMP-compliant lab/equipment via work orders with facilities/metrology.
- Provide input to SOP/test method revisions; participate in investigations, deviations, CAPA, and Change Control.
Minimum Education/Experience/Skills
- BS in Microbiology or closely related field (preferred).
- 0–2 years’ experience (preferred).
- Preferred: microbiology assays/aseptic techniques in a GMP environment; animal injection (SubQ/ID).
- Preferred understanding of cGMP, CFR, USP, and aseptic processing guidelines.
- Required: computer skills (MS Office/MS Project or similar).
- May require weekends/holidays.
Application instruction
- If selected for interview, speak with a Human Resources Partner about compensation philosophy and available benefits.
- Perform daily laboratory testing and sample collection per approved procedures, specifications, and regulatory requirements.
- Conduct sample preparation, execute test methods, accurately document results, and report data timely.
- Ensure testing follows attention to detail, data integrity, and safety standards.
- Support laboratory maintenance: clean/basic equipment maintenance, inventory management, waste disposal, and maintain inspection-ready workspaces.
Essential Functions
- Technical expertise: understand compliance/guidance/regulations for assigned area; perform routine testing/sample collection with supervisory oversight for limited non-routine/validation studies.
- Perform microbiology/bioassay testing (e.g., purity/filtrate/enumeration, aseptic technique; animal injections preferred—SubQ or ID).
- Laboratory support/quality systems: continuous improvement using LEAN (6S+, Kaizen); perform initial review; enter passing results in LIMS; receive/label/restock reagents and supplies; maintain equipment.
- Support GMP-compliant lab/equipment via work orders with facilities/metrology.
- Provide input to SOP/test method revisions; participate in investigations, deviations, CAPA, and Change Control.
Minimum Education/Experience/Skills
- BS in Microbiology or closely related field (preferred).
- 0–2 years’ experience (preferred).
- Preferred: microbiology assays/aseptic techniques in a GMP environment; animal injection (SubQ/ID).
- Preferred understanding of cGMP, CFR, USP, and aseptic processing guidelines.
- Required: computer skills (MS Office/MS Project or similar).
- May require weekends/holidays.
Application instruction
- If selected for interview, speak with a Human Resources Partner about compensation philosophy and available benefits.