Use your expertise to make a difference in disease research and drug discovery around the world. Our custom and catalog products are employed by scientists from global biopharmaceutical corporations and top-tier academic institutions, to actively study \such diseases as Alzheimer’s disease, Multiple Sclerosis, Cancer, Cardiovascular disease, Diabetes, COVID and so much more.

The mission of a Quality Assurance (QA Validation Specialist) is to assist the QA department at AnaSpec Inc. to ensure that products, services, and processes meet a set of predetermined quality standards, regulations, and laws. The goal of a QA Validation Specialist is to validate that products, services, and processes are effective, efficient, and compliant with internal and external quality requirements, such as industry standards, government regulations, and customer expectations.

Responsibilities:

• Provide quality guidance for the development of the validation/qualification approach.
• Ensure correct and timely implementation of procedure change requests. Interact as necessary with appropriate departments to facilitate the review/revision process.
• Check format and conformance to document templates, help write/edit procedures.
• Work with a high degree of accuracy and recall.
• Adhere to strict compliance with written procedures applicable to the job function.
• Maintain training records of employees in Manufacturing and QA/QC Departments.
• Participate in quality system audits.
• Establish and maintain metrics related to documentation control and training.
• Provide support and assistance as necessary on tasks and projects as directed by the manager.
• Ensure implementation, compliance, and continuous improvement of QMS through SOP documentation.
• Ensure that the review, approval of documentation pertinent to equipment, systems validation and qualification is performed on time to achieve compliance to procedures and regulatory requirements.
• Develop and execute test cases, scripts, plan, and procedures.
• Other duties as assigned by Management.

Requirements:

• At least 3 years of relevant experience in the area of quality assurance in the Biotech/Life Sciences arena
• Extensive background in Quality Assurance Validation a plus
• Working experience in ISO 9000, ISO13485, cGMP environment
• Science degree or equivalent preferred
• Experience performing/supporting computer systems validations associated to IQ, OQ & PQ for software systems
• Excellent communication skills, both oral and written