Senior Associate, Quality Assurance - Sterile Operations (Nights)

Resilience; Olde West Chester (OH); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Bonus program

401(k) plan

Healthcare benefits

Paid vacation

Job summary

RESILIENCE is seeking a QA professional to execute quality assurance activities supporting manufacturing within the Drug Product Process Execution Team and adjacent areas. You will review batch records, manage documentation, and drive continuous improvement while ensuring GMP compliance and operational excellence.

The role involves training peers, mentoring Junior Quality Associates, and leading QA processes to maintain timely product and documentation flow in line with site objectives.

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.

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

Skills

Attention to detail

Problem-solving

Training & mentoring

Oral & written comms

Gowning qualification

cGMP knowledge

Team collaboration

Education

Bachelor’s degree in Life Sciences

Master’s degree in Quality/Regulatory Affairs

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

The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship

Sponsorship or support for work authorization, including visas, is not available for this position.

Equal Employment Opportunity

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.

Benefits

Resilience offers employees a robust total rewards program including 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, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

Salary

Our target base pay hiring range for this position is $70,000.00 - $115,000.00 per year. 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.

Company Overview

RESILIENCE 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.

Gown Qualifications Requirement

As a requirement of this role, employees must have the ability to demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.