Specialist II, QC Systems jobs in United States
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Resilience · 5 days ago

Specialist II, QC Systems

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Specialist II, QC Systems team member works independently to support the Quality Control Systems group by performing tasks related to Sample Management and Laboratory Instrumentation.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
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Responsibilities

Maintain schedules/calendars within appropriate computerized and non-computerized systems for the following events:
Laboratory Instruments maintenance and Calibration
Stability study initiation, time point pulls, disposal of completed studies
Batch retention initiation, annual inspection, disposal at completion of retention period
Coordinate activities working with internal and external partners for the following items:
Laboratory instrument maintenance and Calibration
Stability study initiation, time point pulls, reporting of data, disposal of completed studies
Batch retention initiation, complaint support, annual inspection, disposal once retention period is complete
Complaints reinspection of retained batches
Facilitate positive vendor relationships through proactive communication: arranging site visits, escorting vendors as necessary and ensuring they have what is required to have a successful site visit
Perform Hands-on Sample Receipt activities as necessary, following all applicable procedures and documentation requirements
Perform Hands-on Retain activities as necessary, following all applicable procedures and documentation requirements
Perform Hands-on Stability activities as necessary, following all applicable procedures and documentation requirements
Perform Hands-on troubleshooting, maintenance and/or calibration activities of lab instruments/equipment as necessary, following all applicable procedures and documentation requirements
Author/Update relevant SOPs as required
Leads continuous improvements for departmental procedures/process execution
Assist with audits as necessary, gathering and providing information as required

Qualification

Stability programsInstrumentation calibrationCGMP knowledgeSample managementRecord keepingComputerized systemsCommunication skillsIndependent work

Required

Experience with stability or retention programs
Must have the ability to effectively understand, read, write, communicate and follow instructions
Ability to work independently
Experience keeping accurate records
Experience using computerized systems to maintain schedules and organization

Preferred

Four year degree
Experience working in or with chemical or microbiological laboratories
Experience with instrumentation calibration and maintenance or monitoring
Knowledge of cGMPs and FDA policies/procedures

Benefits

Annual cash bonus program
401(k) plan with a generous company match
Great healthcare (including medical, dental and vision)
Family building benefits
Life and disability insurance
Flexible time off
Paid holidays
Other paid leaves of absence
Tuition reimbursement
Support for caregiving needs

Company

Resilience

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Resilience is a biomanufacturing company that provides access to complex medicines and protects biopharmaceutical supply chains.

Funding

Current Stage
Late Stage
Total Funding
$3.36B
Key Investors
Oak Hill AdvisorsAdministration for Strategic Preparedness and ResponseMubadala
2025-10-29Debt Financing· $825M
2024-10-03Grant· $17.5M
2023-03-24Debt Financing· $410M

Leadership Team

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William Marth
President & Chief Executive Officer
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Susan Billings
Chief Commercial Officer (CCO)
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Company data provided by crunchbase