QA Specialist: Drug Product & Process Excellence

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

Benefits offered by this job

Annual bonus

401(k) with company match

Healthcare package (medical, dental, V

Paid vacation and holidays

Tuition reimbursement

Caregiving support

Job summary

Resilience in West Chester, PA, is seeking a Quality Assurance professional to execute QA activities supporting manufacturing processes within the Drug Product Process Execution Team (DPPET) and related areas. This role focuses on batch record reviews, documentation control, and continuous improvement to ensure compliance and operational excellence.

You will train peers, mentor junior staff, and lead QA processes including batch review and issue resolution, aligning with GMP expectations across

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 complete gowning qualification.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.

Responsibilities

• Maintain understanding of production processes and quality systems.
• Perform QA review of batch records and related documentation for accuracy and compliance.
• Collaborate across the organization to ensure consistent application of quality standards.
• Train peers and mentor junior Quality Associates; maintain batch review tracker.
• Execute and lead QA processes, including batch record review and issue resolution.
• Partner with site groups on projects impacting PET areas while ensuring GMP during planning, execution, and closeout.
• Drive process improvements and perform risk assessments; benchmark QA practices for innovative solutions.
• Monitor regulatory changes and advise site leadership on implementation.
• Support data analysis and development of quality metrics and KPIs.

Skills

Quality Assurance

cGMPs

Attention to detail

Problem-solving

Training/mentoring

Aseptic gowning

Communication

Education

Bachelor’s degree in Quality/Regulatory Affairs

Master’s degree in Quality/Regulatory Affairs

Job description

Resilience in West Chester, PA, is seeking a Quality Assurance professional to execute QA activities supporting manufacturing processes within the Drug Product Process Execution Team (DPPET) and related areas. This role focuses on batch record reviews, documentation control, and continuous improvement to ensure compliance and operational excellence.

You will train peers, mentor junior staff, and lead QA processes including batch review and issue resolution, aligning with GMP expectations across