Senior QA Associate: Manufacturing Quality & Process Improvement

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

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.