Quality Technician II, Aseptic Control (Day Shift - 12-Hour Rotating Schedule)

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:

This position is responsible for autonomously performing tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. (Day Shift - 12-Hour Rotating Schedule)

Position Responsibilities:

• Perform routine sampling activities and associated data entry.

• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.

• Read and interpret diagrams, drawings, and other schematics.

• Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.

• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).

• Complete required training.

• Perform visual inspections.

• Use MODA to collect and analyze samples.

• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.

• Ensure that others carry out laboratory duties in a manner consistent with cGMP.

• Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.

• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.

• Provide feedback on service and quality issues on a timely basis.

Hours (Day shift):

• 6 AM - 6 PM (12-Hour Shift)
• Rotating 2-2-3 shift schedule

Minimum Qualifications:

• Prior experience in a pharmaceutical production environment

• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language

• Thorough attention to detail is required

• Must be capable of keeping accurate records and performing mathematical calculations

Preferred Qualifications:

• B.S. in biology or other related discipline

• Working knowledge of MODA, Microsoft applications

• Experience working in a LEAN manufacturing environment

• Knowledge of cGMPs and FDA policies/procedures

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.