Quality Technician II (Night Shift)

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.

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Position Summary:

The Quality Technician II (Night Shift) should autonomously perform tasks related to environmental monitoring to support the regulatory requirements of a sterile manufacturing site. This position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting.

NOTE: This is a Night Shift position (12 hour shift, 2/2/3)

Job Responsibilities:

• 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.

• 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.

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

• Provide 24/7 "on-call" support to others.

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

• This position requires shift work with weekends and occasional extended shifts with possible short-notice schedule shift changes

Minimum Qualifications:

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

• Good attention to detail is required.

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

Preferred Qualifications:

• High school graduate, vocational school graduate, or equivalent

• Two years of experience in a pharmaceutical production environment

• Working knowledge of MODA, Microsoft applications, SAP, KRONOS, and Trackwise

• Experience working in a LEAN manufacturing environment

• Knowledge of cGMPs and FDA policies/procedures

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.