Associate II, Quality Assurance

A career at Resilience is more than just a job its an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that9s changing the way medicine is made. Were 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.

Position Summary

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

Job Responsibilities

• Maintain a high level of understanding of relevant production processes and quality systems
• Perform the QA review and approval of GMP documentation including Change Requests, Batch Records, Product and Component Release transactions in SAP, Quality Investigations, Validation Plans, Protocols and Reports, and Standard Operating Procedures
• Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Execute QA processes including batch record review, product disposition, and quality issue resolution to meet site objectives
• Interface with site support groups on projects impacting PET/assigned area ensuring GMP compliance
• Facilitate process improvements and risk assessments; benchmark QA practices to identify innovative efficient and effective methods
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies
• Collaborate in data analysis and report creation on quality metrics and KPIs

Minimum Qualifications

• Experience in pharmaceutical industry, operations environment, or Quality Assurance
• Excellent oral and written communication skills
• Strong ability and motivation to learn

Preferred Qualifications

• Bachelors degree; masters in quality assurance/regulatory affairs is desirable
• Experience in Lean, process-centric organizations with emphasis on continuous improvement
• Multi-site / multi-functional experience
• Considerable experience in Quality Assurance

This position may include performing AQL testing subject to passing qualifications and eye exams.

Additional Information: This is a night shift position (12-hour rotating, 2/2/3 schedule). Resilience offers a robust total rewards program including cash bonus, 401(k) with match, healthcare benefits, tuition reimbursement, family building benefits and more.

Target base pay hiring range: $60,000 - $90,000 per year, dependent on location, experience, and qualifications.