Quality Technician II (Night Shift)

Quality Technician II

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.

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

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 (i.e., laboratory notebooks, quality records, and sample receipts)
• Complete required training
• Perform visual inspections
• Use the Environmental Monitoring System 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 is maintained in a state of compliance
• Provide feedback on service and quality issues on a timely basis

Hours (Night Shift):

• 6pm - 6:30am
• 2/2/3 Schedule (12-Hour Rotating)

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

• High school graduate, vocational school graduate, or equivalent
• Working knowledge of MODA, Microsoft applications, SAP, KRONOS
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship or support for work authorization, including visas, is not available for this position.

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 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, paid vacation, 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 - $30.50 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.