QA Associate - Laboratory

QA Associate

A Day in the Life As a QA Associate, you'll be responsible for assisting multiple projects where you will have increasing interaction with our multi-disciplinary staff, regulatory agencies and clients. You will be part of a strong team of committed professionals.

The hourly compensation range for this role is $20.00 to $23.00, commensurate with experience, skills, and geographic location.

Schedule:

Monday - Friday

To thrive in this role, you'll be comfortable taking ownership of the following responsibilities:

• Track or perform verifications of laboratory supply equipment to ensure operational reliability per SOP and manufacturer specifications.
• Perform daily/weekly reviews of appropriate logbooks, bench sheets, or data for Good Documentation Practices (GDP) compliance.
• Initiate and address non-conformances for corrective actions.
• Collect and interpret quality control data, create control charts, and audit sample reports to track lab performance and identify trends.
• Track CAPA and perform or assist with Root Cause Analysis (RCA).
• Conduct routine internal audits of laboratory processes, documentation, and facilities.
• Prepare audit checklists, reports, and follow-up on findings.
• Accurate and timely communication with internal and external clients.
• Draft, review, and/or revise SOPs, work instructions, forms, or other controlled documents.
• Review and enter Proficiency Testing (PT) data and results.
• Troubleshooting and problem-solving.
• Develop and deliver in-laboratory GDP, ethics, data integrity, safety, and technical training.
• Maintain training records and competency assessments.
• Archive documents in accordance with SOPs.
• Review laboratory data, workflows, and procedures to ensure accuracy and compliance with TNI 2016, ISO 17025, client requirements, and our robust quality system.
• Support external audits.
• Communicating relevant updates to applicable people in a timely manner.
• Adhere to documented quality manual, policies, and health and safety practices and protocols (i.e., use of PPE, chemical hygiene, and waste handling).
• Take on additional duties and responsibilities as needed to support our dynamic lab team.

Your Expertise and Skills

These requirements reflect the knowledge, skills and abilities that help you do your best work here.

• Bachelor's degree or equivalent in a scientific field, or a combination of education, training, and experience.
• 1+ years of relevant experience working in a laboratory or quality assurance role (or equivalent).
• Strong understanding of scientific terminology, analytical laboratory procedures, and lab safety.
• Understanding of physical and chemical principles underlying why procedures are specified the way they are for each method with which they work.
• Good written and verbal communication, with sharp editorial and proofreading abilities.
• Ability to collaborate with lab teams to gather, interpret, and document data.
• Good organization, time management, and communication skills and able to facilitate priorities in an effective manner.
• Proficiency in Microsoft Office (e.g., Word, Excel, SharePoint, and PowerPoint).
• Familiarity with TNI 2016, ISO 17025 standards, GDP, CAPA, or RCA is a plus.
• Experience with LIMS.
• Proficiency using and data visualization tools for reports and graphs.
• Conflict resolution skills and removes/breakdowns organizational communication barriers.
• Assertion skills-problem diagnosis, assess corrective action, not blame.
• Ability to handle multiple tasks simultaneously while maintaining composure.
• A team player who can work independently and thrives in a collaborative, fast-paced, quality-driven environment.

Work Environment and Physical Requirements

The physical and environmental requirements below reflect what's typically needed to perform the essential functions of this role safely and effectively. We may provide reasonable accommodation to qualified individuals with disabilities, consistent with applicable law, to support performance of the essential functions.

• Sitting, standing, and walking
• Lifting 50 pounds several times a day
• Overhead lifting of over 20 pounds
• Works in an office and/or laboratory environment
• May be exposed to hot and cold environments and extreme weather conditions, including sunlit, rainy and windy conditions
• May occasionally work shifts up to 12 hours in duration
• Ability to work occasional evenings or weekends based on workload demands.

We are an Equal Opportunity Employer. We are committed to providing access and reasonable accommodation in its employment for individuals with disabilities.