QA Compliance Specialist (Life Sciences) jobs in Kentucky

​A Life Sciences QA (Quality Assurance) Compliance Specialist is responsible for ensuring that a company operating in the life sciences industry, such as pharmaceuticals, biotechnology, or medical devices, complies with applicable regulations, standards, and quality systems. Their role is critical in maintaining product quality, safety, and efficacy, as well as meeting regulatory requirements.

Here are some key responsibilities of a Life Sciences QA Compliance Specialist:

1. Regulatory Compliance: They ensure that the company complies with relevant regulations, guidelines, and standards set by regulatory authorities such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). This involves staying up-to-date with the latest regulatory requirements and implementing necessary changes within the organization.

2. Quality Systems Development: They develop, implement, and maintain quality systems and processes to ensure compliance with applicable regulations. This includes creating standard operating procedures (SOPs), work instructions, and quality manuals that define how activities should be performed to maintain quality standards.

3. Auditing and Inspection: QA Compliance Specialists conduct internal audits to assess compliance with established quality systems and identify areas for improvement. They may also prepare for and participate in external audits and inspections conducted by regulatory agencies or customers.

4. Documentation Control: They establish and maintain systems for document control, including the review, approval, distribution, and archival of quality-related documents. This ensures that all documentation is accurate, up-to-date, and easily accessible when needed.

5. Training and Education: QA Compliance Specialists provide training and education to employees on quality systems, procedures, and regulatory requirements. They ensure that employees are aware of their responsibilities and understand the importance of compliance in maintaining product quality and patient safety.

6. Risk Assessment and Management: They identify potential risks and develop strategies to mitigate those risks. This involves conducting risk assessments, implementing risk management plans, and monitoring the effectiveness of risk mitigation measures.

7. Corrective and Preventive Actions (CAPA): When quality issues or non-compliance are identified, QA Compliance Specialists coordinate and oversee the implementation of corrective and preventive actions. They investigate root causes, develop action plans, and monitor the effectiveness of these actions to prevent recurrence.

8. Change Control: They evaluate and manage changes to processes, procedures, or equipment that may impact product quality or compliance. This involves assessing the impact of proposed changes, obtaining necessary approvals, and ensuring appropriate documentation of change control activities.

A Life Sciences QA Compliance Specialist plays a crucial role in maintaining quality and regulatory compliance within the life sciences industry. They work to ensure that products are developed, manufactured, and distributed in accordance with applicable regulations and quality standards, ultimately safeguarding patient health and well-being.

​Kentucky has a presence in the life sciences field. While Kentucky is often associated with industries like agriculture and bourbon production, the state also has a growing life sciences sector. Several universities, research institutions, and biotech companies in Kentucky are actively engaged in various areas of life sciences research and development. These include:

1. University of Kentucky: The University of Kentucky has a strong life sciences program, with research and academic departments dedicated to fields such as biology, biochemistry, molecular biology, genetics, neuroscience, and more. The university also houses the Markey Cancer Center, which focuses on cancer research and treatment.

2. University of Louisville: The University of Louisville is another major institution with a strong emphasis on life sciences. It has departments and research centers dedicated to biomedical sciences, cardiovascular research, cancer research, neurology, and other related fields.

3. Kentucky Bioprocessing (KBP): KBP, a subsidiary of the global biotech company Alltech, is located in Lexington, Kentucky. It specializes in the production of pharmaceuticals and vaccines using plant-based technologies.

4. Kentucky BioProcessing (KBP): KBP, a subsidiary of the global biotech company Alltech, is located in Owensboro, Kentucky. It specializes in the production of pharmaceuticals and vaccines using plant-based technologies.

5. Kentucky Science Center: Located in Louisville, the Kentucky Science Center is a science museum that offers educational programs and exhibits related to various scientific disciplines, including life sciences.

6. The Coldstream Research Campus: Situated in Lexington, the Coldstream Research Campus is a 735-acre business park focused on research and development. It is home to various companies and organizations engaged in life sciences research, including biotechnology and pharmaceutical companies.

These are just a few examples of the life sciences presence in Kentucky. The state is actively working to promote and grow its life sciences sector by fostering collaboration between academia, industry, and government entities.