QA Specialist (Life Sciences) jobs in Florence

​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.

​Florence, Kentucky is increasingly becoming a hub for life sciences companies and research organizations in the greater Cincinnati metro area. Here's an overview of the life sciences landscape in Florence:

• Part of the Northern Kentucky region, which has seen growth in biosciences over the last decade. The area has sought to attract pharma/biotech companies.

• Home to a campus of Cincinnati Children's Hospital Medical Center, a leading pediatric research hospital. This enables clinical trials, medical R&D, and a pipeline of talent.

• The Florence area specifically has a cluster of pharmaceutical companies like Meridian Bioscience, APIC Corporation, Ashland Chemical Company focused on drug manufacturing and diagnostic testing.

• Strong university presence with the University of Cincinnati and Northern Kentucky University providing skilled graduates for the industry.

• Right across the river from Cincinnati which has major companies like P&G, Kroger, and Kao brands which need R&D support and offer partnership opportunities.

• Part of the Kentucky Innovation Network and KY Biomedical Innovation Group initiatives to build up life sciences in the state. Access to tax incentives.

• Centrally located in the Midwest with good transportation infrastructure via Cincinnati/Northern Kentucky International Airport.

In summary, Florence offers a skilled workforce, research institutions, an existing cluster of pharma companies, and geographic access to partnerships that collectively make it an attractive emerging hub for life sciences in the US.