Responsibilities
- Execute and review routine in-process, drug substance, and stability testing methods in a timely manner.
- Use lab instrumentation/computer systems (e.g., LIMS, SoftmaxPro, Charles River Endoscan, MODA, Empower) to collect and record data.
- Maintain lab operations (cleaning, ordering supplies, reagent prep, stocking, waste disposal).
- Conduct facility monitoring tests (Environmental Monitoring, Critical Utilities) and product/in-process testing.
- Author/own quality system events (laboratory investigations, deviations, CAPA, change controls) in the electronic Quality Management System.
- Maintain data integrity and comply with SOPs/specifications/cGMP; independently troubleshoot within QC procedures.
- Draft studies/investigations; author new SOPs and update existing procedures; train new QC Analysts.
- Perform equipment maintenance/calibrations; complete mandatory training; other duties as assigned.
Qualifications / Skills (Required/Preferred)
- Bachelorโs or masterโs degree in Life Sciences with relevant lab coursework.
- 3โ6 years relevant experience preferred; regulated-environment experience preferred.
- Must understand laboratory instrumentation; knowledge of cGMP manufacturing.
- Knowledge of chemical/biological/microbiological safety procedures.
- Basic computer skills (word processing, spreadsheets, databases).
- Effective communication; read/write/speak English; good interpersonal skills; eagerness to learn/improve.
Schedule / Conditions
- Saturday to Tuesday shift; may require overtime/shift changes; possible on-call/off-shift support; cold/wet controlled environment; may require PPE.
Compensation & Benefits (as stated)
- Hourly wage range: $24.76โ$38.87; eligible for certain insurance/401(k), tuition reimbursement, paid time off, sick time, and incentives (per company terms).
Application instructions
- Apply via the โApplyโ button (acknowledge Privacy Notice/Terms of Use).