Quality Assurance Coordinator

Quality Assurance Coordinator 1

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At ALS, we encourage you to dream big.
When you join ALS, you join a purpose and values-driven team that empowers you to innovate, create, and thrive.

Our global team turns up each day with passion and commitment to do amazing things, always challenging our thinking to find ways to solve some of the world’s most complex problems for a safer, healthier world.

About the role
The Quality Assurance Coordinator 1 will be responsible for reviewing and ensuring the integrity and compliance of all clinical trial data, processes, and environment at ALS-Clinical, Irving by performing the duties outlined below. The training and duties for this job are adherent to all current good clinical practices.

The Quality Assurance Coordinator 1 has the following duties:

o Checks the patch booths before they are opened to ensure that the patch type and testing conditions are correct
and patches have test article on them
o Verifies the humidity and temperature of retain closet, test article closet, drug closet, server room and archive
room and ensure that they are within the range
o Verifies if there are any test articles on the floor inside the retain closet, test article closet and drug closets
o Verifies temperature for incubators, refrigerators and freezers and ensure that the temperature is within specified
range
o Verifies that balances are level
o Verifies balances for calibration and calibrate if needed
• Ensures data integrity throughout all stages of data capture and reporting, including source data verification against electronic records and exported datasets (I did not see this)
• Conducts internal audits (including unannounced audits) and supports external audits by clients or regulatory agencies. Tracks and trends audit findings and ensures timely implementation of CAPAs.
• Assists in always maintaining inspection readiness, including mock audit preparation, documentation control, and staff training record reviews.
• Participates in investigations and root cause analyses for deviations, protocol violations, or client complaints.
• Identifies and implements process improvements related to quality operations in coordination with cross-functional teams.
• When applicable, witnesses jar fill prior to study start
• Reviews Informed Consent Forms signed by subjects and Medical History Forms
• Conducts In-study audits
• Inventories the test articles that are received and enter them into the respective inventory log
• Maintains Standard Operating Procedures
• Maintains Standard Training Procedures
• Ensures that the studies are compliant with protocols and ALS Clinical, Irving Standard Operating Procedures and are conducted in compliance with Good Clinical Practices
• Assists Quality Assurance Coordinator II or Manager, Quality Assurance in writing new Standard Operating Procedures when necessary
• Maintains keys to restricted areas (retain closet, drug closets, test article closet and archives)
• Attends protocol meetings for assigned studies
• Maintains Signature/Initials log, Curriculum Vitae binder for physicians.
• Assists Quality Assurance Coordinator II with verifying training records, Curriculum Vitae for employees, Standard Operating Procedure and Standard Training Procedure acknowledgements from employees.
• Ensures equipment (timer, pipettes and thermometers) and standard weights are checked for calibration on a regular basis, monthly expiration check.
• Ensures that Fume Hood is checked for certification every six months
• Assist Manager, Quality Assurance with other tasks as assigned
• Reviews Study Administrative Notebooks/regulatory binder prior to the beginning of the study.
• Reviews Data sheets for completeness and accuracy
• Reviews data tables to ensure accuracy of data
• Reviews data tables after statistical analyses are performed to ensure accuracy of the data
• Reviews Serious and non-serious Adverse events to ensure subject’s safety and accuracy of reported data
• Maintains retain samples of test articles and log them into the retain log
• Maintains accountability for test articles during the course of the study until the study ends
• Attends study status meetings and give an update on their study status
• Performs other duties as may be assigned from time to time

Position Requirements 

• Bachelor's Degree (BA/BS) in Science or equivalent from a four-year college or technical school, or six months to one year related experience and/or training, or equivalent combination of education and experience.
• Needs 5-6 years of experience in a clinical setting
• Certificates , licenses, and registrations recommended: Current certificate for: Human Protections, Good Clinical Practices, Bloodborne Pathogens
• Computer skills required: Internet Software, Database (FileMaker Pro), Microsoft Office (Word, Excel), Email (Microsoft Outlook)).


Working conditions:
• Sitting and/or standing for extended periods of time, up to eight (8) hours per business day
• Must be able to stand, bend, push, pull, stoop and crouch frequently while performing the duties of this position
• Must be able to lift (with both hands) and/or move up to 50 pounds and occasionally lift and/or move heavier loads with assistance
• Must be able to interact and communicate effectively with panelist

Working at ALS

Our people are our most valuable asset and drive our success at ALS.
We are a diverse community of dedicated professionals united by our passion to make a difference in the world. We reward excellence and uphold our values in our work and how we treat each other.

At ALS, you’ll be supported to expand your skills and develop new ones so you can reach your full potential. We invest in our people with a range of programs and provide opportunities across the company, giving our people scope to grow diverse careers and develop as leaders.
We want everyone to have a safe, flexible and rewarding career that makes a positive impact on our people, the planet and the communities where we work.

Our benefits include:
• Comprehensive benefit package including medical, dental, and vision coverage, life and disability insurance, retirement plan with company match, employee assistance and wellness programs, access to company perks
• Annual structured wage increases
• PTO
• Business support for education or training after 9 months with the company
• Learning & development opportunities (unlimited access to e-learnings and more)

About ALS

ALS is a global leader in scientific testing, providing comprehensive testing solutions to clients in more than 60 countries across a wide range of industries, including environment, food and beverage, mining, personal care, pharmaceutical, healthcare and equipment reliability. Using state-of-the-art technologies and innovative methodologies, our dedicated international teams deliver the highest-quality testing services and personalized solutions supported by local expertise. We help our clients leverage the power of data-driven insights for a safer and healthier world.

Everyone matters

ALS is proud to be an equal opportunity employer committed to achieving and maintaining a workforce which reflects and affirms the diversity of our society

ALS is a VEVRAA Federal Contractor.

EOE AA Minority, Female, Veteran, Individuals with Disabilities.

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ALS also welcomes applications from people with all levels of ability. Accommodation is available on request for candidates taking part in all aspects of the selection process.