Senior Associate, Quality Assurance - Sterile Operations (Nights)
Resilience
Summary
This position is responsible for executing Quality Assurance (QA) activities that directly support manufacturing processes within the Drug Product Process Execution Team (DPPET), as well as in assigned areas outside of the Process Execution Teams (PETs). Key activities include, but are not limited to, batch record review, documentation management, continuous improvement initiatives, and practical problem-solving to ensure compliance and operational excellence.
Job description
Position Summary
This position is responsible for executing Quality Assurance (QA) activities that directly support manufacturing processes within the Drug Product Process Execution Team (DPPET), as well as in assigned areas outside of the Process Execution Teams (PETs). Key activities include, but are not limited to, batch record review, documentation management, continuous improvement initiatives, and practical problem-solving to ensure compliance and operational excellence.
Job Responsibilities
- Maintain a high level of understanding of relevant production processes and quality systems
- Perform QA review of batch records and associated documentation to ensure accuracy and compliance
- Collaborate with and influence other professionals across the organization to ensure consistent application and execution of key quality standards
- Responsible for performing department training for peers, mentoring junior Quality Associates, and maintaining the batch review tracker
- Execute and lead QA processes, including batch record review and quality issue resolution, to support timely product and documentation flow in alignment with site objectives
- Partner 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
- Work collaboratively with PET/assigned area personnel to drive process improvements and conduct risk assessments; benchmark internal and external QA practices to identify innovative and efficient solutions
- Monitor evolving regulatory requirements and recommend implementation strategies to site leadership
- Support data analysis and the development of reports related to quality metrics and key performance indicators
Minimum Qualifications
- Prior experience in the pharmaceutical industry or Quality Assurance
- Demonstrated knowledge of cGMPs and Quality Systems
- Strong attention to detail
- Problem-solving skills
- Ability to train and mentor peers
- Ability to gown aseptically and successfully complete aseptic gowning qualification
- Excellent oral and written communication skills
- Strong ability and motivation to learn
Preferred Qualifications
- Bachelor’s degree: Master’s degree in Quality/Regulatory Affairs is desirable
- Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
- Multi-site / multi-functional experience
- Advanced experience in Quality Assurance
Work Schedule
Monday - Friday; 5pm - 1:30am
Requirements
- Prior experience in the pharmaceutical industry or Quality Assurance
- Demonstrated knowledge of cGMPs and Quality Systems
- Strong attention to detail
- Problem-solving skills
- Ability to train and mentor peers
- Ability to gown aseptically and successfully complete aseptic gowning qualification
- Excellent oral and written communication skills
- Strong ability and motivation to learn
Benefits
- Annual cash bonus program
- 401(k) plan
- Company match
- Medical insurance
- Dental insurance
- Vision insurance
- Family building benefits
- Life insurance
- Disability insurance
- Paid vacation
- Paid holidays
- Paid leaves of absence
- Tuition reimbursement
Company overview
Resilience (National Resilience, Inc.) is a technology-focused contract development and manufacturing organization (CDMO) 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 that advanced therapies can be made quickly, safely, and at scale. Resilience specializes in manufacturing complex modalities including biologics, vaccines, nucleic acids, cell and gene therapies, and drug products. With facilities across North America, the company partners with leading biopharma companies to bring innovative medicines to market faster and more reliably. Their capabilities span biologics drug substance manufacturing, cell-based therapies, and aseptic drug product manufacturing for both small and large molecules. Resilience's mission is to free its partners to focus on scientific discoveries while advancing the science of biopharmaceutical manufacturing through cutting-edge technologies and integrated digital systems.