Senior QA Specialist: DSM Validation & Compliance

Olon USA LLC; Concord Township (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Olon USA LLC in Concord, OH is seeking a Senior Quality Assurance Specialist to drive QA oversight of Drug Substance Manufacturing processes through to commercial release in a cGMP facility.

You will develop and approve validation plans, risk assessments, and lifecycle documentation; lead QA procedures; coordinate with cross-functional teams and regulatory inspections; and ensure on-time delivery of quality objectives.

Qualifications

• Bachelor's degree in a technical field (Chemical Engineering, Chemistry or related)
• 5+ years of relevant chemical processing experience in a GMP/regulated setting
• Experience with validation of production equipment and manufacturing systems, and knowledge of 21 CFR Parts 210, 211 and 11

Responsibilities

• Serve as Subject Matter Expert for QA documents, processes, and procedures in the DSM program.
• Oversee validation lifecycle activities and change management to keep systems validated from startup through commercial operation.
• Approve quality lifecycle documentation, risk/impact assessments, specs, traceability matrices, protocols, and validation reports.
• Develop and approve QA procedures for validation approaches and lifecycle documents for Manufacturing Systems.
• Support QA of manufacturing operations in a cGMP facility and ensure timely achievement of quality objectives.
• Collaborate with other Olon sites to optimize processes and efficiency.
• Participate in optimization initiatives and support regulatory agency and third-party inspections.
• Lead quality meetings, review batch records, and provide QA oversight on floor activities.

Skills

Communication

Time management

Critical thinking

Validation

Data Integrity

cGMP

Team collaboration

Regulatory inspections

Education

B.S. in Chemical Engineering, Chemistry or technical discipline

Job description

Olon USA LLC in Concord, OH is seeking a Senior Quality Assurance Specialist to drive QA oversight of Drug Substance Manufacturing processes through to commercial release in a cGMP facility.

You will develop and approve validation plans, risk assessments, and lifecycle documentation; lead QA procedures; coordinate with cross-functional teams and regulatory inspections; and ensure on-time delivery of quality objectives.