Specialist II, Quality 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

Position Responsibilities

• Support the preparation, planning, logistics, and execution of the activities related to client audits and inspections.

• Actively support the Logistics Center during an external audit/inspection.

• Participate in the established review cycle of QA-controlled documents to assure practices reflect written procedures.

• Coordinate and support GxP Documentation Control Systems to include the issuance of controlled documents and maintenance of site GxP records.

• File and maintain archived records and documentation

• Perform data entry

• Prepare documentation of activities, actions, and/or results

• Complete required training

• Ensure proper documentation practices during job activities

• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions

• Write, review, and/or revise SOPs (Standard Operating Procedures) for maintenance of area equipment, systems, and processes

• Gather, organize, and communicate operational information to others

• Coordinate document and record archival with representatives from other departments

• Monitor records to ensure compliance with regulatory requirements

• Review completed documentation for quality, completeness, and cGMP (Good Manufacturing Practices) compliance

• Alert manager when issues occur outside of area documentation

• Attend team meetings to discuss progress, initiatives, and/or other matters

• Able to multi-task

• Able to work on task(s) for an extended period

Minimum Qualifications

• Basic knowledge of cGMP concepts

• Experience in MS Office applications and data management applications

• Strong interpersonal skills to interact with internal departments and outside contractors

• Excellent communication skills (both written and verbal)

Preferred Qualifications

• Bachelor's degree in a science or other technical field

• Prior competence as an advanced user type (such as super user or administrator)

• Prior experience in the pharmaceutical industry including experience in data and documentation management

• Proficiency in MS Office applications and data management applications such as EDMS, LIMS, and SAP

• Demonstrated expertise in IS/IT management and data management and manipulation

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 $50,000.00 - $72,500.00 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.