Associate II, Quality Assurance (Night Shift)
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
General Company Description
Resilience (Resilience US, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. Resilience will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients’ lives.
For more information, visit www.resilience.com.
Position Summary & Responsibilities
The Associate II, Quality Assurance will be responsible for all Quality Assurance activities that directly support the execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include the following: batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, regulatory interactions, and other assigned quality duties.
- Maintains a high level of understanding of relevant production processes and quality systems
- Performs 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
- Product and Component Release transactions in SAP
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols, and Reports
- Standard Operating Procedures
- Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Executes QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Interfaces with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensures GMP compliance during the planning, execution, and closeout phases of these projects
- Collaborates with, and influences, other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient, and effective practices
- This position is a night shift 6 pm-6 am. Week 1 is Monday - Wednesday and Week 2 is Monday - Thursday
- Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
- Experience and demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment
- Bachelor’s degree or Master’s degree in Quality Assurance /Regulatory Affairs or related field
- Previous experience in a Lean, process-centric organization with an emphasis on continuous improvement
- Stays up to date on evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Excellent oral and written communication skills
- Strong ability and motivation to learn
- Strong problem-solving skills
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 annualized base pay hiring range for this position is $62,000.00 - $78,500.00. 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.