Senior QA Lead — GMP Compliance & Process Integrity

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

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Comprehensive healthcare benefits

Job summary

A technology-focused biomanufacturing company in Ohio seeks a Quality Assurance professional to oversee critical QA activities in operations. The role requires extensive knowledge of GMPs and Quality Systems, with responsibility for batch release and regulatory compliance. Candidates should have a degree in quality assurance or regulatory affairs and demonstrate strong communication skills. This position offers a competitive salary range from $70,000 to $115,000, plus a robust benefits package.

Qualifications

• Prior experience in the pharmaceutical industry or Quality Assurance.
• Strong understanding of Quality Systems and the pharmaceutical supply chain.
• Ability to work independently with minimal guidance.

Responsibilities

• Manage QA activities supporting Operations Teams.
• Approve GMP documentation impacting operations.
• Collaborate on quality system applications.

Skills

Knowledge of cGMPs

Excellent communication skills

Problem-solving skills

Ability to coach and mentor

Education

Bachelor’s or master’s degree in quality assurance/regulatory affairs

Job description

A technology-focused biomanufacturing company in Ohio seeks a Quality Assurance professional to oversee critical QA activities in operations. The role requires extensive knowledge of GMPs and Quality Systems, with responsibility for batch release and regulatory compliance. Candidates should have a degree in quality assurance or regulatory affairs and demonstrate strong communication skills. This position offers a competitive salary range from $70,000 to $115,000, plus a robust benefits package.