Project Management Qc Specialist

Ian Ballard

Objective

Experienced validation and QA/QC specialist with a strong background in biopharmaceutical manufacturing, interdepartmental cooperation, and project management. Seeking new opportunities to leverage my expertise in a dynamic environment.

Education

• Associate of Arts in Computer Electronics

Merritt University, Oakland, CA (1981–1983)

• Bachelor of Science in Biology

San Francisco State University, San Francisco, CA (1984–1989)

Work Experience

Validation Specialist

Cetus Corporation (1989–1992)

• Participated in the start-up validation of a biopharmaceutical manufacturing facility.

• Verified piping, air ducting, and air balancing systems, and validated autoclaves, dry heat ovens, lyophilizers, and bottle washers.

• Sampled gases and water for injection to ensure quality standards.

• Worked collaboratively with Engineering, Facility, and Operations departments to ensure smooth facility operations.

Contract Validation Specialist

Life Science Inc. (LSI) (1992–1994)

• Performed validation of gene sequencers, freeze dryers, autoclaves, bottle washers, and various manufacturing equipment.

• Delivered contract-based services across local pharmaceutical companies.

• Maintained strong interdepartmental relationships with Engineering, Operations, and Compliance teams to meet validation requirements.

QA/QC Specialist

Shaklee Corporation (1996–1998)

• Managed QA/QC operations in a GMP-compliant nutraceutical and experimental drug manufacturing environment.

• Conducted validation of mixers, graters, and material handling equipment.

• Collaborated with Engineering, Production, and Laboratory departments to ensure material control and release of GMP-standard materials.

QA/QC Specialist

Yamanucci Pharmaceuticals (1998–2001)

• Oversaw QA/QC tasks at a pharmaceutical manufacturing facility, ensuring compliance with FDA GMP standards.

• Facilitated the validation of equipment post-relocation of the facility.

• Worked closely with the Facility, Operations, and Engineering teams to ensure smooth integration and ongoing compliance.

Owner/Operator

Handyman and Landscaping Business (2001–2024)

• Successfully operated a sole proprietorship, providing handyman and landscaping services for over two decades.

• Developed strong client relationships, completing projects in line with customer expectations and timelines.

• Coordinated projects with homeowners, utilizing engineering and operational insights from prior career experience.

Skills

• Validation and Quality Assurance

• GMP Compliance

• Interdepartmental Collaboration (Engineering, Operations, Facility)

• Equipment and Process Validation

• Project Management

• Technical Writing and Documentation

References

Available upon request.

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