Associate II, Quality Assurance

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

Position Summary & Responsibilities
This position is responsible for all QA activities that directly support the process's execution 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.

• Maintain a high level of understanding of relevant production processes and quality systems
• Perform the QA review and approval of the following GMP documentation that has a direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
  • 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, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
• Collaborate with and influence other 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

Hours (Night Shift):

• 6 PM-6 AM
• 2 nights on, 2 nights off, 3 nights on, 3 nights off and the rotation starts over

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

This position may also include the following conditions:
[QA Associates' ability to perform the AQL process are subject to passing an eye exam]

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.