Pharma QA Oversight Specialist — On-Floor Compliance

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 74,000 - 100,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

FSA/HSA

Life insurance

AD&D

Job summary

Jubilant HollisterStier in Spokane, WA is hiring a QA Oversight Specialist to ensure manufacturing and QC operations meet quality standards and regulatory requirements. You will support floor operations, liaise between production and QA, and help drive compliance and continuous improvement on the manufacturing floor.

Responsibilities include real-time floor oversight in aseptic environments, facilitating investigations, implementing corrective actions, and reviewing batch records.

Qualifications

• Bachelor of Science Degree or 4 years of technical manufacturing experience in lieu of degree required
• Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years of direct pharmaceutical experience required
• FDA Regulated Industry required
• Proficiency In Microsoft Word, Excel and PowerPoint Required
• Able To Follow Detailed Instructions required
• Excellent Interpersonal Skills Required
• Able to Navigate Differing Opinions required
• Problem Solving Skills required

Responsibilities

• Regulatory Compliance: Ensure procedures and practices align with US and European regulatory standards
• On-the-Floor Oversight: Real-time oversight of Manufacturing and QC operations in aseptic environments
• Observation and Reporting: Provide daily/weekly/monthly summaries and ensure corrective actions
• Problem Identification and Mitigation: Identify issues and collaborate on resolutions
• Deviation Investigation: Ensure thorough, documented investigations
• Independent and Collaborative Problem Solving: Solve problems individually and in teams
• Aseptic Processing Oversight: QA oversight for aseptic processing and controlled environments
• Training Support: Assist in onboarding and training new QA Oversight personnel
• Quality System Review: Review quality system records for accuracy and compliance
• Continuous Improvement: Update SOPs to evolving standards
• On the floor batch record review: Daily review of batch records to ensure ALCOA++
• Ability to don sterile gowns

Skills

Regulatory compliance

MS Office proficiency

Quality systems

Problem solving

Interpersonal skills

Detail orientation

Education

Bachelor of Science Degree

4 years technical manufacturing experience

Tools

MS Word

MS Excel

PowerPoint

Job description

Jubilant HollisterStier in Spokane, WA is hiring a QA Oversight Specialist to ensure manufacturing and QC operations meet quality standards and regulatory requirements. You will support floor operations, liaise between production and QA, and help drive compliance and continuous improvement on the manufacturing floor.

Responsibilities include real-time floor oversight in aseptic environments, facilitating investigations, implementing corrective actions, and reviewing batch records.