Analyst II, Incoming Quality Control

Resilience US; Olde West Chester (OH); In loco; USD 60.000 - 75.000; Tempo pieno

Descrizione del lavoro

Resilience US in Ohio seeks an IQC lead to oversee day-to-day inspection, sampling, and testing activities, directing technicians to meet material release goals. You will act as the primary link between IQC and cross-functional teams, ensuring accuracy and compliance with cGMP standards.

You will review data, manage documentation in CMMS/ERP, and drive continuous improvements while collaborating with Supply Chain, Manufacturing, and Quality Assurance to prioritize releases and uphold quality

Competenze

• Experience in a pharmaceutical or cGXP-regulated environment with ability to self-direct inspections and sampling.
• Effective English communication and meticulous documentation to ensure traceability.
• Proven ability to lead a team of technicians, set priorities, and hold peers accountable.
• Bachelor's degree in business or related discipline preferred; 3+ years in pharma or regulated settings.

Mansioni

• Plan and execute inspection, sampling, and testing to meet material release schedules.
• Perform visual and physical inspection of incoming materials against specs and drawings.
• Interpret quality standards to determine release readiness and verify labeling and storage.
• Operate and troubleshoot inspection equipment and maintain related records.
• Prepare and maintain cgMP documentation and review data for compliance.
• Use CMMS and ERP systems to track material status and logistics.
• Collaborate with Supply Chain, Manufacturing, and QA to align release priorities.
• Provide on-the-job training and share process knowledge with technicians.

Conoscenze

Leadership

Quality inspection

cGXP compliance

Documentation

English communication

Formazione

Bachelor's degree in business or related discipline

Strumenti

CMMS

ERP systems

Descrizione del lavoro

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

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 ( 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 assignment