Analyst II, Incoming Quality Control

About the position

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.

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 a continuous basis.
• Coordinate with representatives from other departments, represent IQC in cross-functional meetings.
• Perform testing of samples.
• Maintain and troubleshoot 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.)

Requirements

• 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.

Nice-to-haves

• High school graduate, vocational school graduate or equivalent.
• Experience in a pharmaceutical environment supporting incoming quality.

Benefits

• Equity
• Annual cash bonus program
• 401(k) plan with a generous company match
• 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
• Support for caregiving needs