QA Oversight Specialist — On-Site Aseptic Pharma

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

Benefits offered by this job

Medical, Dental & Vision coverage

FSA/HSA

Life & AD&D Insurance

Short-Term & Long-Term Disability

Job summary

Jubilant HollisterStier Spokane is seeking a QA Oversight Specialist to ensure manufacturing and quality control operations comply with regulatory standards. You will provide real-time floor support and act as a liaison between production teams and Quality Assurance.

The role includes on-the-floor oversight in aseptic environments, deviation investigations, batch record reviews, and driving continuous improvement.

Qualifications

• Bachelor of Science Degree or 4 years of technical manufacturing experience in lieu of degree.
• 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
• In-Depth Understanding of the Relationship Between Regulatory Requirements, Operating Procedures, And Ensuring Compliance in A Production Environment 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 all procedures and practices within Manufacturing and Quality Control align with applicable US and European regulatory standards.
• On-the-Floor Oversight Conduct real-time oversight of Manufacturing and QC operations while in controlled aseptic environments to verify that products meet labeling, dating, and packaging requirements per SOPs and cGMP.
• Observation and Reporting:Provide daily, weekly, and monthly summaries of floor observations, respond to findings, and ensure timely completion of corrective actions.
• Problem Identification and Mitigation: Recognize potential quality issues, review and approve mitigation strategies, and collaborate with department supervisors to resolve deficiencies in product quality or systems.
• Deviation Investigation: Ensure investigations into facility or support system deviations are thorough, accurate, and adequately documented.
• Independent and Collaborative Problem Solving Demonstrate the ability to solve complex problems both independently and within cross-functional teams.
• Aseptic Processing Oversight: Provide QA oversight for aseptic processing while present within controlled environment to ensure sterility and compliance. Obtaining and maintaining access to controlled environment is required.
• Training Support: Assist in onboarding and training new QA Oversight personnel to maintain consistency and quality standards.
• Quality System Review: Review and approve quality system records, ensuring accuracy and regulatory compliance.
• Continuous Improvement: Proactively revise SOPs related to job functions to align with evolving industry standards and best practices.
• On the floor batch record review: Perform daily review of on the floor manufacturing batch records to ensure compliance with ALCOA++ principles.
• Ability to don sterile gowns.

Skills

MS Word

MS Excel

PowerPoint

Regulatory knowledge

Problem solving

Interpersonal skills

Education

Bachelor of Science Degree

4 years of technical manufacturing experience in lieu of degreerequired

Tools

Microsoft Office

Job description

Jubilant HollisterStier Spokane is seeking a QA Oversight Specialist to ensure manufacturing and quality control operations comply with regulatory standards. You will provide real-time floor support and act as a liaison between production teams and Quality Assurance.

The role includes on-the-floor oversight in aseptic environments, deviation investigations, batch record reviews, and driving continuous improvement.