QC Analyst II, Data & Sample Management

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

Position Summary:

The QC Analyst II, Data & Sample Management will ensure the quality of laboratory data and reports. This role will perform accurate and timely technical review of QC data, ensuring compliance to cGMPs and to Resilience Standard Operating Procedures (SOPs), while meeting clients' deliverables.

The QC Analyst II, Data & Sample Management will review a variety of data including, but not limited to, flow cytometry, qPCR and ddPCR data. This individual will utilize technical skills to perform in-depth problem solving, proactively identify opportunities for continuous improvements, and assist in resolving laboratory investigations, as needed. This individual will also collect and evaluate analytical data to trend assays and monitor critical reagent performance.

The QC Analyst II, Data & Sample Management will be responsible to maintain the critical reagent inventory for the QC Analytical team. The person will closely collaborate with Technical Subject Matter Experts (SMEs) and QC Management team to ensure all critical reagents are deemed suitable and properly qualified prior to GMP use. The individual will support the QC-Analytical operation team with management of general inventory to ensure proper on-boarding of new reagents as part of Resilience New Product Introduction (NPI) program.

Position Responsibilities:

• Perform QC technical, scientific and compliance review of data and documentation generated by the Quality Control laboratories, including reports associated with method qualifications and/or validations.

• Generate CoAs, as needed.

• Closely work with QC analysts, QC leadership and QA to perform expedited data review and communicate in-process results to Manufacturing.

• Complete all required job specific cGMP, Data Integrity, and EHS trainings and adhere/comply to appropriate standards defined for quality, ethics, health, safety, environment, and information security.

• Understand the requirements, expectations and needs of internal and external customers and interact in courteous, professional, supportive, and collaborative manner.

• Own, author, review/approve and support QC change controls, deviations and other quality records for the East Norriton site, as applicable.

• Compile analytical data and report trend data for QC.

• Maintain critical reagent inventory and oversee the execution of any qualification activities, as required to meet project timelines.

• Closely work with Supply Chain and Procurement teams to assess and on-board new reagents required to support Resilience NPI program.

• Support QC-Analytical Operation team with regards to general reagent inventory, including placing and receiving orders.

• Support other Quality initiatives, as needed.

Minimum Qualifications:

• Familiarity with GMP laboratory requirements.

• Familiarity with analytical methods.

• Familiarity with inventory management systems.

Preferred Qualifications:

• Bachelor of Science degree in Biology, Biochemistry, Molecular Biology or other relevant fields, A combination of relevant education and experience will be considered in lieu of degree.

• 2+ years of experience in a laboratory setting.

• Working understanding of flow cytometry, PCR and ELISA assays

• Experience with Laboratory Information Management System (LIMS) and electronic laboratory notebook (ELN)

• Experience with maintaining laboratory inventory of reagents and samples.

• Knowledge and experience with cGMP Quality Systems.

Other Ideal Personal Characteristics:

• Demonstrated ability to take ownership, initiative, and self-accountability.

• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.

• Attention to detail and quick learning/application of concepts and information.

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.