Project Management Quality Assurance

Ian Ballard

**** *********** **, *******, **

510-***-**** ********@*****.***

Objective

Experienced validation and QA/QC specialist with a strong background in biopharmaceutical manufacturing, interdepartmental collaboration, and project management. Seeking a role where my expertise can contribute to operational excellence and regulatory compliance. I also have a good aptitude working with electrical and mechanical equipment.

Education

Bachelor of Science in Biology

San Francisco State University – San Francisco, CA

Associate of Arts in Computer Electronics

Merritt University – Oakland, CA

Professional Experience

Owner/Operator — Handyman and Landscaping Business

Berkeley. 2001–2024

• Managed a successful sole proprietorship providing handyman and landscaping services for over 20 years.

• Delivered projects within specified timelines, ensuring customer satisfaction and repeat business.

• Applied engineering and operational expertise from prior career to enhance project execution and outcomes.

• Performed house and business fixes and upgrades including building out a new reflexology studio, plumbing, electrical work, installation of wallboard, and general yard maintenance.

QA/QCSpecialist — Yamanouchi PharmaceuticalsPalo Alto] 1998–2001

• Oversaw quality assurance and quality control activities in compliance with FDA GMP standards.

• Led equipment validation projects following facility relocation, ensuring seamless integration and compliance.

• Partnered with Facility, Operations, and Engineering teams to meet production goals.

QA/QC Specialist — Shaklee Corporation

Hayward] 1996–1998

• Managed QA/QC functions in a GMP-regulated nutraceutical and experimental drug environment.

• Validated mixers, graters, and material handling equipment.

• Collaborated with Engineering, Production, and Laboratory teams for material release and control.

Contract Validation Specialist) LSI (Life Sciences Incorporated))

Pleasanton] 1992–1994

• Delivered validation services for gene sequencers, freeze dryers, autoclaves, and manufacturing equipment.

• Provided contract-based validation support to pharmaceutical clients, ensuring compliance and operational efficiency.

• Fostered collaboration with Engineering, Operations, and Compliance teams to meet client expectations.

Validation Specialist — Cetus Corporation

Emeryville ] 1989–1992

• Contributed to the start-up validation of a biopharmaceutical manufacturing facility.

• Conducted validation of autoclaves, dry heat ovens, lyophilizers, and bottle washers.

• Partnered with Engineering, Facility, and Operations departments to ensure operational readiness.

Receptionist and Operations Assistant — Pegasus Press

Berkeley ] 1978–1986

• Managed receptionist duties, ensuring professional communication with clients and vendors.

• Handled order entry and invoicing, maintaining accurate records and timely processing.

• Assisted with packing and shipping of customer orders, ensuring quality and timely delivery.• Provided delivery services and supported operational tasks to ensure seamless business operations.

Skills

• Validation and Quality Assurance

• GMP Compliance and Documentation

• Interdepartmental Collaboration

• Equipment and Process Validation

• Technical Writing and Reporting

• Project Management

References

Available upon request.

Contact this candidate