Introduction to Resilience
Imagine being part of a revolutionary biomanufacturing company that's changing the way medicine is made. At Resilience, 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. As a technology-focused company, we're committed to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Our mission is to continuously advance the science of biopharmaceutical manufacturing and development, freeing our partners to focus on the discoveries that improve patients' lives.
Job Overview
We're seeking a highly skilled and experienced Senior Specialist II, Quality Assurance to join our team. As a key member of our Quality Assurance team, you will be responsible for all QA activities that directly support the execution of the process both within the Sterile Ops Process Execution Team (PET) and in assigned areas outside of the PETs. This is a fully remote opportunity, offering a competitive salary package commensurate with experience. If you're ready to take the next step in your career and be part of a thriving team, we encourage you to apply now!
Key Responsibilities
- Maintain a high level of understanding of relevant production processes and quality systems
- Perform QA review and approval of GMP documentation, including change requests, batch records, and quality investigations
- Accountable for disposition (release or rejection) of incoming materials, bulk product, and filling product
- 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
- Interface with applicable site support groups on projects that impact the PET/assigned area, ensuring GMP compliance during planning, execution, and closeout phases
- Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments
- 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
Essential Qualifications
- Significant experience in the pharmaceutical industry, operations environment, or Quality Assurance
- Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment
- Excellent oral and written communication skills
- Strong ability and motivation to learn
- Strong problem-solving skills
- Ability to coach and mentor peers
Preferred Qualifications
- Bachelor's or master's degree in a science or technical field, such as pharmacy, biology, chemistry, or engineering
- Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
- Multi-site/multi-functional experience
- Considerable experience in Quality Assurance
- Experience with SAP, FMEA execution and upkeep, and pharmaceutical PQS
- Additional technical experience or background in Sterile Manufacturing, aseptic/sterile manufacturing, contamination control, and EM
Career Growth and Learning Benefits
At Resilience, we're committed to helping our employees grow and develop in their careers. As a Senior Specialist II, Quality Assurance, you'll have the opportunity to:
- Develop and deliver training content in areas of expertise
- Act as execution lead/process owner for one or more processes
- Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
- Demonstrate leadership capabilities and train and mentor junior members of the QA organization
- Provide QA coaching to other non-QA employees within the area supported
Work Environment and Company Culture
At Resilience, we're proud of our company culture, which is built on a foundation of innovation, collaboration, and continuous improvement. As a fully remote company, we offer a flexible and adaptive work environment that allows our employees to thrive. Our team is passionate about making a difference in the lives of patients, and we're committed to creating a work environment that is inclusive, supportive, and empowering.
Compensation, Perks, and Benefits
We offer a competitive salary package, commensurate with experience, as well as a range of perks and benefits, including:
- Equity
- Annual cash bonus program
- 401(k) plan with a generous company match
- Comprehensive benefits package, including medical, dental, and vision
- Family building benefits
- Life and disability insurance
- Flexible time off and paid holidays
- Tuition reimbursement and support for caregiving needs
Conclusion
If you're a motivated and experienced Quality Assurance professional looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Senior Specialist II, Quality Assurance at Resilience, you'll be part of a dynamic team that's changing the face of biomanufacturing. Don't miss out on this chance to join a revolutionary company and take your career to the next level. Apply now and start a conversation with one of our recruiters!
Apply Now