Position Summary
The Senior Associate, Quality Control Microbiology will support facility Environmental Monitoring (EM) programs for sterile product manufacturing, including sampling, testing, data management, aseptic technique/gowning training, investigations, and lab operations (equipment preventive maintenance, supply inventory, and general support). Provides leadership to junior analysts; supports method/SOP revisions, study protocols, method transfers, and qualifications. May support lot release/stability assays, sample preparation/aliquoting, and media lot release testing.
Essential Functions
- Organize daily workload and resource needs.
- Author manufacturing documentation.
- Perform EM/critical systems monitoring, review, reporting, and trending; support investigations/root cause analysis.
- Conduct routine/validation sample testing (GMP or non-GMP); support maintenance and method/equipment qualification/validations.
- Maintain lab equipment (clean/sanitize) and restock/inventory.
- Coordinate/generate risk assessments.
- Draft controlled documents (protocols, reports, SOPs, test methods, specifications, work instructions) and perform data entry/reporting.
Education & Experience
- Bachelorβs in life sciences + 2+ years in a GMP-regulated biologics/pharmaceutical environment (required).
- cGMP aseptic processing facility experience (preferred).
Skills/Abilities
- QC Microbiology regulatory knowledge; environmental/critical utility/personnel monitoring; microbiological testing/aseptic processing.
- Strong technical writing (SOPs, reports, protocols; FDA/EMA support).
- Problem-solving, attention to detail, aseptic technique.
- Proficient with Microsoft Word/Project/Excel; strong communication and independent issue resolution.
Working Environment
- Onsite in El Segundo, CA; off-hours/second shift/weekends as needed; gowning in cleanroom; ~10% travel.
Compensation/Benefits & Application
- Discretionary bonus and equity; hourly base $37.50β$41.25.
- Benefits: Medical/Dental/Vision, EAP, life/AD&D, short/long-term disability, FSAs, 401(k) match, 529, PTO (11 holidays; Unlimited PTO if exempt; non-exempt vacation/health pay/personal/cultural days).
- Application window: closes in 60 days or sooner if filled/closed.