Associate II, Quality Assurance (Night Shift)

About Resilience

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.

Position Summary & Responsibilities

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.

• Maintain a high level of understanding of relevant production processes and quality systems.
• Perform the QA review and approval of GMP documentation that has direct impact on the activities performed by, and facilities utilized in, their corresponding areas, including:
  • Change Requests
  • Batch Records and associated documentation
  • Product and Component Release transactions in SAP
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols and Reports
  • 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 maintain the flow of products and documents to meet site objectives.
• Interface with applicable site support groups on projects (capital and non‑capital) that impact the PET/assigned area, proactively ensuring GMP compliance during planning, execution, and closeout phases.
• Collaborate with and influence PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative, efficient, and effective practices.
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders.
• Collaborate in data analysis and report creation on quality metrics and key performance indicators.
• At this level the incumbent may begin by specializing in one or more responsibilities while developing solid knowledge of the process and applicable cGMPs.

Minimum Qualifications

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

Preferred Qualifications

• Bachelor’s degree; master’s degree in science is desirable.
• Previous experience in a Lean, process‑centric organization with an emphasis on continuous improvement.
• Multi‑site / multi‑functional experience.
• Sponsorship or support for work authorization, including visas, is not available for this position.

Benefits

• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Comprehensive healthcare including medical, dental, and vision.
• Family building benefits.
• Life and disability insurance.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.

Pay

Target base pay hiring range: $60,000.00 – $90,000.00 per year. Actual base pay depends on factors such as geographical location, relevant experience, qualifications, skills, and knowledge.

Schedule

Night Shift: 6 PM – 6:30 AM. Rotation: 2 days on, 2 days off, 3 days on, 3 days off, then repeat.