Analyst II, Incoming Quality Control

About the role

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.

Job Summary

Leads day-to-day IQC operations, directing the work of technicians to meet inspection and release goals. Self-directs own inspection and sampling tasks and serves as the primary operational link between IQC and cross-functional departments.

Job Responsibilities

Inspection, Sampling & Testing

• Independently plan and execute own inspection, sampling, and testing activities to meet material release schedules, prioritizing work based on production and business needs
• Perform visual and physical inspections of incoming materials and components against specifications, drawings, and schematics; verify identity, quantity, and characteristics
• Interpret quality standards and specifications to determine whether incoming materials meet requirements for release
• Verify that incoming materials are received, labeled, stored, and segregated in accordance with procedures
• Operate, maintain, and troubleshoot inspection and testing equipment

Documentation, Data Review & Compliance

• Prepare and maintain accurate cGMP documentation of activities and results, including logbooks, quality records, and sample receipts
• Review IQC records and data for accuracy, completeness, and compliance with cGMP and regulatory requirements
• Use CMMS and ERP systems to track material status, inventory, and logistics
• Perform periodic reviews of IQC SOPs and work instructions; identify gaps and draft revisions for approval

Issue Resolution & Continuous Improvement

• Identify non-conformances and deviations affecting incoming materials or IQC processes; troubleshoot and determine corrective actions within own scope, escalating issues beyond that scope to the supervisor
• Implement temporary and permanent fixes to recurring issues and contribute to longer-term IQC process improvements

Collaboration & Knowledge Sharing

• Partner with Supply Chain, Manufacturing, and Quality Assurance to coordinate inspection and release priorities; represent IQC in cross-functional meetings as needed
• Serve as a technical resource for technicians and peers; answer compliance and process questions and provide on-the-job training on IQC procedures, systems, and equipment
• Communicate status of own inspection and release work to the supervisor and stakeholders
• Experience & Education

Minimum Qualifications

• Experience in a pharmaceutical or cGXP-regulated environment, with demonstrated ability to self-direct inspection and sampling activities and coordinate the work of others without close supervision
• Ability to communicate effectively in English and to document activities in accordance with cGMP; attention to detail and ability to maintain accurate records
• Demonstrated ability to lead or direct the day-to-day work of a team of technicians; ability to assign tasks, set priorities, and hold others accountable for completing work to standard
• Ability to independently identify non-conformances, determine corrective actions within own scope, and represent IQC in cross-functional settings
• Preferred Qualifications
• Bachelor's degree in business or a related discipline
• 3+ years of experience in a pharmaceutical or regulated environment supporting incoming quality

Physical & Work Environment

• This is primarily a non-sedentary role.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• Occasional (20-60% of time): sitting, walking, and monitoring other people's work.
• Infrequent (<20% of time): lifting/carrying up to 30 lbs., working at heights of 5 ft., bending, stooping, twisting, reaching, noise exposure, operating moving machinery, chemical usage with potential exposure to area chemicals requiring handling precautions per SOP, traveling, and speaking publicly.
• Interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors; seeing with 20/20 (or better) vision, with or without correction.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

Work Schedule: 8 hours - Monday- Friday

Available to provide 24/7 on call support when requested.

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, including a request to work overtime, 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. This role requires the ability to provide 24/7 on-call support as needed.

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

Pay and benefits

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 $60,000.00 - $86,250.00 per year. 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? We encourage you to apply and start a conversation with one of our recruiters.