Specialist II, QC Systems

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Job Summary:

The Specialist II, QC Systems team member works independently to perform administrative and hands-on tasks focused on Sample Management (Stability Program, Retains Program, Sample Receipt) and Laboratory Instrumentation within the Quality Control Systems group in support of the QC Chemistry and Microbiology laboratories

Position 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.

Minimum Qualifications

• 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 Qualifications

• 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.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.