Specialist II, MSAT

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 & Responsibilities
* Maintain an advanced knowledge of the SAP system and execute SAP transactions as required to complete process orders.
* Create, revise, and assist with preparation of GxP documentation.
* Facilitate generation and approval of SOPs (Standard Operating Procedures), work instructions, validation documentation and MBRs (Master
Batch Records).
* Review completed GxP documentation for quality, completeness, and cGMP compliance.
* Coordinate cross-functionally with other departments as required.

* Attend team meetings to discuss progress, initiatives, and/or other matters.
* Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures).

Minimum Qualifications
1. Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
2. Good attention to detail is required. Individual must be capable of keeping accurate records.

3. Display Organizational skills and the ability to execute to a timeline.

4. Strong Technical Writing and Communication Skills.

Preferred Qualifications
1. High school graduate, vocational school graduate or equivalent, Bachelor's degree or equivalent

2. Experience working in a LEAN manufacturing environment
3.. Knowledge of cGMPs and FDA policies/procedures

4. Experience in an electronic document management system.
5. Experience in a pharmaceutical or cGMP regulated environment.

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.