QA Specialist (Life Sciences) jobs in Brea

​A life sciences Quality Assurance (QA) Specialist plays a crucial role in ensuring compliance with regulatory standards and quality requirements within the life sciences industry. Their primary responsibility is to implement and maintain quality systems and processes to support the development, manufacturing, and distribution of pharmaceuticals, medical devices, biotechnology products, or other life sciences-related products.

Here are some key tasks and responsibilities of a life sciences QA Specialist:

1. Quality Systems Management: Developing, implementing, and maintaining quality management systems (QMS) that comply with relevant regulations and industry standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). This includes document control, change control, deviation management, and CAPA (Corrective and Preventive Actions) processes.

2. Compliance Monitoring: Conducting regular internal audits and inspections to assess compliance with regulations and standards. This involves reviewing procedures, protocols, and records to identify any non-compliance issues and recommending corrective actions.

3. Regulatory Compliance: Staying up-to-date with applicable regulations, guidelines, and standards in the life sciences industry. Ensuring that products and processes are compliant with regulatory requirements, such as those set by the Food and Drug Administration (FDA) or other relevant regulatory bodies.

4. Validation and Qualification: Participating in validation and qualification activities for equipment, systems, and processes. This includes developing validation plans, executing validation protocols, and reviewing validation documentation to ensure compliance and data integrity.

5. Training and Education: Providing training to personnel on quality systems, procedures, and regulatory requirements. Ensuring that employees are aware of and adhere to quality standards, practices, and policies.

6. Risk Management: Collaborating with cross-functional teams to identify and assess risks related to product quality and regulatory compliance. Developing risk mitigation strategies and implementing risk management practices to prevent potential issues.

7. Investigation and Root Cause Analysis: Leading or supporting investigations into quality incidents, deviations, and customer complaints. Conducting root cause analysis and implementing corrective and preventive actions to address underlying issues.

8. Supplier and Vendor Management: Evaluating and monitoring suppliers and vendors to ensure they meet quality requirements. This involves conducting audits, assessing supplier performance, and managing supplier-related documentation.

9. Continuous Improvement: Driving continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes. This includes analyzing quality metrics, conducting trend analysis, and implementing process improvements.

10. Regulatory Inspections and Audits: Assisting with regulatory inspections and audits by providing documentation, answering questions, and supporting compliance efforts during inspections conducted by regulatory authorities or external auditors.

A life sciences QA Specialist plays a critical role in ensuring that products meet the highest quality standards and comply with regulatory requirements. They contribute to maintaining patient safety and product integrity throughout the life cycle of life sciences products.

​Brea, California is known for its strong presence in the life sciences industry. The city has a favorable environment for life sciences companies and research institutions due to its proximity to major research centers, universities, and biotechnology hubs in Southern California.

One significant advantage of Brea is its location within close proximity to several renowned academic and research institutions. The University of California, Irvine, is approximately 15 miles away, and California State University, Fullerton, is about 10 miles away. These institutions offer resources, talent, and potential collaboration opportunities for life sciences professionals and businesses.

Furthermore, Brea is located near established biotechnology and pharmaceutical hubs, including South San Francisco and San Diego. These regions are known for their concentration of life sciences companies, research institutions, and venture capital investment.

Brea itself hosts a variety of life sciences companies, including those engaged in biotechnology, pharmaceuticals, medical device manufacturing, and healthcare services. The city has a supportive business climate, with resources available for startups and established companies alike. Additionally, Brea benefits from its proximity to major transportation networks, including airports and major highways, facilitating the movement of goods and personnel.

Brea, California, offers a favorable environment for life sciences professionals and companies. Its location, access to talent and research institutions, and proximity to biotechnology hubs make it an attractive destination for individuals and businesses in the field.