Quality Assurance Lead - Night Shift, Sterile Ops

Resilience; North Olmsted (OH); Hybrid; USD 70,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Healthcare benefits

Paid time off

Job summary

Resilience in West Chester, OH is seeking a Senior Associate, Quality Assurance - Sterile Operations (Nights) to execute QA activities that support Drug Product Process Execution and related areas. You will review batch records, manage documentation, mentor colleagues, and help ensure GMP compliance throughout manufacturing.

You will lead QA processes, partner with site teams on upgrades, monitor regulatory changes, and contribute to continuous improvement in sterile operations during night

Qualifications

• Experience in pharmaceutical Quality Assurance and aseptic environments.
• Strong knowledge of cGMPs and Quality Systems.
• Ability to train and mentor peers; attention to detail.

Responsibilities

• Perform QA review of batch records and documentation for accuracy and compliance.
• Lead QA processes and resolve quality issues to support timely product and documentation flow.
• Collaborate across site to ensure GMP compliance and drive process improvements.

Skills

QA knowledge

cGMPs knowledge

Problem-solving

Training & mentoring

Aseptic gowning

Communication

Education

Bachelor’s degree in a related field

Master’s degree in Quality/Regulatory Affairs (desirable)

Job description

Resilience in West Chester, OH is seeking a Senior Associate, Quality Assurance - Sterile Operations (Nights) to execute QA activities that support Drug Product Process Execution and related areas. You will review batch records, manage documentation, mentor colleagues, and help ensure GMP compliance throughout manufacturing.

You will lead QA processes, partner with site teams on upgrades, monitor regulatory changes, and contribute to continuous improvement in sterile operations during night