QA Compliance Specialist (Life Sciences) jobs in Chaska

​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.

​Chaska, Minnesota is home to several life sciences companies and organizations. While it may not be as well-known as some other major life sciences hubs, Chaska has a presence in the industry due to the following factors:

1. Beckman Coulter Life Sciences: One notable company with a significant presence in Chaska is Beckman Coulter Life Sciences. They specialize in developing and manufacturing scientific instruments and solutions for biomedical research, clinical diagnostics, and drug discovery. Beckman Coulter's facility in Chaska focuses on developing and producing products for life sciences applications.

2. Biotechnology and Medical Device Companies: Chaska is also home to various biotechnology and medical device companies that operate in the life sciences field. These companies are engaged in research, development, and manufacturing of products ranging from biopharmaceuticals to medical devices used in diagnostics and therapies.

3. Academic and Research Institutions: Chaska benefits from its proximity to renowned research and academic institutions in the Twin Cities area. The University of Minnesota, for example, is a leading institution with strong expertise in life sciences, biotechnology, and medical research. Collaboration and knowledge exchange between these institutions and local companies contribute to the life sciences presence in Chaska.

While Chaska's life sciences industry may not be as extensive as some other well-established hubs, it has a niche presence with notable companies and access to nearby resources. The specific companies and organizations in Chaska may evolve over time, so it is advisable to research the current landscape and developments in the area.