Senior Analyst, Quality Control

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 Senior Analyst, Quality Control will support establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy products. This includes performing data review, deviation investigations, CAPA ownership, change control management, and trending of environmental and utility monitoring data, ensuring a compliant Quality Control lab.

The candidate will interface with Manufacturing, Facilities, Quality Assurance, Engineering and other functions as required. A strong cGMP, operational and technical background in microbiological methods and environmental monitoring will be needed. This position will also require hands on laboratory time including bioburden testing, endotoxin testing, growth promotion, and plate reading. The level of the position filled will be commensurate with experience.

Minimum Qualifications:

• Direct experience authoring deviations and performing root cause analysis

• Experience performing documentation and review within a LIMS system

• Hands on experience with environmental monitoring, bioburden, endotoxin, and other Microbiological methods.

• Direct experience in authoring/reviewing/approving SOPs and Technical Reports.

Preferred Qualifications:

• Superb organizational, analytical, and communications skills

• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment

• Demonstrate a strong initiative and ownership of assigned projects

• Minimum BS in Microbiology or other related field.

• 3+ years experience in cGMP/GxP environment.

This position may also include the following conditions:
This position will require hands on laboratory time and require the analyst to be able to meet requirements to perform work in the classified manufacturing spaces.

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

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.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with 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 and support for caregiving needs. Our target base pay hiring range for this position is $75,000.00 - $112,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.