Analyst II, Incoming Quality Control

Company: Resilience
Location: West Chester
Posted on: April 21, 2025

Job Description:

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 Position Responsibilities:

• Train others on systems, software, equipment, machines, procedures and/or processes.
• Review complete documentation for quality, completeness, and cGMP compliance.
• Answer compliance and process questions from others.
• Conduct troubleshooting activities.
• Communicate priorities and progress to team on continues basis.
• Coordinate with representatives from other departments, represent IQC in cross functional meetings.
• Performs testing of samples. Maintains and troubleshoots testing equipment.
• 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.
• Ensure that weights, measures, and raw materials are managed appropriately so that manufactured batches contain proper ingredients and quantities.
• Perform visual inspections.
• Verify count, measure and check materials to ensure proper components, quantities, and/or characteristics.
• Use CMMS (Computerized Maintenance Management System) to manage logistics. Use SAP to track inventory and materials.
• Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups.
• Identify temporary and permanent fixes to address issues.
• Monitor records to ensure compliance with regulatory requirements.
• Create, generate, type, proof, and distribute correspondences.
• Ensure that incoming materials are inspected and released.
• Ensure that others carry out laboratory duties in a manner consistent with cGMP.
• Interpret quality standards to ensure all incoming materials comply with requirements.
• 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 24/7 "on-call" support to others.
• Provide feedback on service and quality issues on a timely basis.
• Provide general office support (for example: directing calls, filing, photocopying, and so on.)Minimum Qualifications:
  • Experience in a pharmaceutical or cGXP regulated environment
  • Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
  • Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.Preferred Qualifications:
    • High school graduate, vocational school graduate or equivalent
    • Experience in a pharmaceutical environment supporting incoming quality.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.Resilience offers employees a robust total rewards program including equity, 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, flexible time off, 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 - $82,500.00 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Keywords: Resilience, Middletown , Analyst II, Incoming Quality Control, Professions , West Chester, Ohio