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Senior Associate, Quality Assurance - Sterile Operations (Nights)
Resilience
USA
Full-time
Senior
Onsite
Discovered 3 weeks ago
Communication
Role Overview
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.
Key Skills for This Role
Communication
Full Job Posting
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 or support for work authorization, including visas, is not available for this position.
- 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.
- 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.
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
- 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 or support for work authorization, including visas, is not available for this position.
- 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.
- 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.
About Resilience
Pharmaceutical Manufacturing1312 employeesFounded 2020
Biomanufacturing CDMO serving biopharmaceutical companies with end-to-end manufacturing for complex medicines.
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