What are the responsibilities and job description for the Clinical QA Specialist position at ALS?
Overview
Clinical QA Specialist
Imagine your future with us
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.
Responsibilities
About the role
This full time, onsite position will report directly to the Quality Assurance Director in the Phoenix office. The Clinical QA Specialist may also work closely with the Clinical Director to ensure the research studies are conducted under company SOP’s and to Good Clinical Practice guidelines. The position is Monday to Friday, from 7:30 AM to 4:00 PM, but must also be flexible to work from 5:30 AM to 2:00 PM for sequestered clinical studies.
Duties Include But Not Limited To
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
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
Click Here to view the EEO is the Law poster
Click Here to view the FMLA Law poster
Click Here to view the EPPA Law Poster
Click Here to view the Pay Transparency Provision
Click Here to view company E-Verify Participation Poster
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.
Clinical QA Specialist
Imagine your future with us
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.
Responsibilities
About the role
This full time, onsite position will report directly to the Quality Assurance Director in the Phoenix office. The Clinical QA Specialist may also work closely with the Clinical Director to ensure the research studies are conducted under company SOP’s and to Good Clinical Practice guidelines. The position is Monday to Friday, from 7:30 AM to 4:00 PM, but must also be flexible to work from 5:30 AM to 2:00 PM for sequestered clinical studies.
Duties Include But Not Limited To
- Review of raw data and associated clinical reports for accuracy and compliance.
- Assist with the administration of the controlled document system, including standard operating procedures, protocols, forms, and supporting documents.
- Assist with maintenance of archives of completed clinical notebooks, study files and master documents, including interactions with external archival storage facilities, as necessary.
- Assist with set-up of new employees.
- Perform review / approval of Deviations, Corrective / Preventive Action (CAPA) proposals and other quality related requests as assigned.
- Assist with internal audits as assigned and follow up with recommendations and corrective actions.
- Ensure all procedures applicable to Clinical Operations are followed.
- Perform all duties following current SOP’s.
- Work with QA Management on special projects as assigned.
- Life Science Bachelor’s Degree (Biology, Chemistry) Minimum of six (3) years of relevant experience in a clinical or quality-oriented role, preferably within an FDA regulated industry.
- Reliable with a strong commitment to quality.
- Multi-tasking and team player.
- Organized, detail oriented, competent, and responsible.
- Good technical writing and communication skills.
- 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
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
- Structured wage increases
- 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 )
- Additional vacation days for years of service
- Business support for education or training after 9 months with the company
- Learning & development opportunities (unlimited access to e-learnings and more)
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
Click Here to view the EEO is the Law poster
Click Here to view the FMLA Law poster
Click Here to view the EPPA Law Poster
Click Here to view the Pay Transparency Provision
Click Here to view company E-Verify Participation Poster
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.