QC & QA Chemist &Technical Writer

Precision Analytical (PA), creators of the DUTCH Test, is looking for a QC & QA Chemist, Technical Writer, and Document Manager to help support our company growth and further our mission of providing the best diagnostic tools in functional medicine.  PA is an exciting place to develop your skills, take care of client needs, and be a part of a dynamic team.

This role will work onsite in our McMinnville, OR location.

We care about your time and interest to know next steps in our recruitment process.  To show this, all applicants will receive a personalized response within 3 business days.  

Job Summary:

We are seeking an experienced and motivated individual to join our clinical lab as a QC & QA Chemist, Technical Writer and Document Manager. This hybrid position involves a combination of laboratory and documentation responsibilities.

Primary Duties and Responsibilities:

Quality Control and Quality Assurance:

• Perform daily quality control checks on laboratory equipment, reagents, and supplies to ensure that they are functioning properly and providing accurate results. Monitor laboratory testing procedures and results to ensure accuracy and reliability.
• Develop and implement quality control procedures and policies to ensure compliance with industry standards and regulations.
• Monitor quality control metrics and investigate any deviations from expected results. Develop and implement corrective and preventative actions to address any quality-related issues.
• Develop and implement quality assurance policies and procedures to ensure compliance with industry standards and regulations.
• Conduct internal and external audits to ensure that laboratory operations meet regulatory requirements and quality standards.
• Work collaboratively with laboratory staff and management to identify areas for improvement and implement quality improvements.
• Develop and deliver training programs on quality control and quality assurance procedures and policies. Ensure that laboratory staff are trained and knowledgeable on quality control and quality assurance procedures and policies. Provide ongoing education and training to laboratory staff to ensure compliance with industry standards and regulations.

Technical Writing:

• Create and maintain documentation related to laboratory operations and processes. This includes standard operating procedures (SOPs), work instructions, training manuals, and other documents that support laboratory activities. The technical writer must ensure that all documentation is clear, concise, and accurate.
• Develop LIMS training and operation manuals based on FRS documents. The LIMS manual to accurately reflect the laboratory's workflows and requirements including sample processing, batch prep, batch extraction, assay data processing, data aggregation, and report generation etc.
• Work closely with subject matter experts (SMEs) within the lab. SMEs may include laboratory staff, quality control and quality assurance personnel, and other technical experts. The writer must be able to communicate with SMEs to understand laboratory workflows and processes and to incorporate this information into the documentation.
• Responsible for reviewing and editing all laboratory documents to ensure that they are accurate, clear, and complete. This includes reviewing documents for grammatical and typographical errors, as well as ensuring that all information is up-to-date.
• Ensure that all laboratory documentation complies with industry standards and regulatory requirements. This may include ensuring that all documents are properly formatted, contain required information, and are updated as needed.
• Responsible for managing all laboratory documentation. Refer to Document Management for
• Responsible for training laboratory staff on new or updated documentation. This includes ensuring that staff understand the documentation and how to use it effectively.

Document Management:

• Responsible for developing and implementing document control procedures that ensure all laboratory documents are properly created, reviewed, approved, distributed, and archived.
• Responsible for maintaining the document management system and ensuring that it is operating effectively. This includes monitoring the system for performance, troubleshooting issues, and coordinating with IT personnel as needed.
• Oversees the review and approval process for all laboratory documents. This includes ensuring that documents are reviewed and approved by appropriate personnel, such as laboratory staff, quality control and quality assurance personnel, and laboratory manager/director.
• Responsible for ensuring that all laboratory documentation complies with industry standards and regulatory requirements. This includes ensuring that documents are up-to-date and that all changes are properly documented.
• Responsible for controlling the distribution of laboratory documents to ensure that only authorized personnel have access to them. This includes ensuring that documents are properly labeled and that access is controlled through the document management system.
• Responsible for archiving laboratory documents according to industry standards and regulatory requirements. This includes ensuring that all archived documents are easily retrievable and that they are properly secured to prevent unauthorized access.

Qualifications:

• Bachelor's degree in Chemistry or a related field.
• Experience in quality control and quality assurance in a clinical laboratory setting.
• Experience with technical writing and documentation management. Knowledge of the LIMS functionality and capabilities
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Familiarity with regulatory requirements and industry standards for laboratory testing.

Work environment:

This position is located in an office/lab environment with frequent use of laboratory instruments and tools, computer and related hardware.  A person must be able to stand and/or sit and effectively move around the building and lab workspaces; see, hear and talk; use hands to type, handle or feel tools or controls; use hands and arms to reach.

This position requires lifting up to 25lbs, and use of PPE when working with urine, saliva, or other samples, or with chemicals and other substances, within our lab environment.