QA Document Coordinator

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

This position provides data and documentation management support to key Pack PET (Process Execution Team) QA functions. The incumbent supports the documentation needs and handling in the Pack QA Quality function.

• 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
• Revise and route SOPs (Standard Operating Procedures), specifications, and other related QA documents in the system for review and approval
• Gather, organize, and communicate operational information to others
• Coordinate document and record archival with representatives from other departments
• Gather, organize, and communicate required metrics for QA I the functional area
• Review completed documentation for quality, completeness, and cGMP (Good Manufacturing Practices) compliance
• Attend team meetings to discuss progress, initiatives, and/or other matters
• Able to multi-task
• Scan required documents for clients
• Prepare batch documentation pre and post-production
• Able to work on task(s) for an extended period

Minimum Qualifications

• Basic knowledge of cGMP concept
• 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

• High school graduate, vocational school graduate, or equivalent
• Prior experience in the pharmaceutical industry including experience in data and documentation management
• Proficiency in MS Office applications and data management applications.
• Demonstrated expertise in IS/IT management and data management and manipulation.

This position may also include the following conditions:

The following is a checklist of a number of the principal physical and mental requirements of a position with Resilience. This document is intended to accompany, and should be read in conjunction with, the job description for the position. This is not intended as an exclusive list of essential functions for the position. Certain general requirements and functions – such as regular and predictable attendance at work and working cooperatively with co-workers – apply to all positions at Resilience and are not specifically listed here.

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 $21.50 - $28.50 per hour. 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.