Clinical Quality Assurance Specialist
Overview
ALS is one of the world's largest and most diversified testing and technical services providers, with sites strategically located in more than 350 locations, in 55 countries, and on six continents providing accurate and timely services to clients in the life sciences, food, pharmaceutical and minerals market sectors, with employees located in multiple sites across the USA. Our corporate headquarters is in Brisbane, Australia however we have a Global Operations (Corporate) center in Houston, Texas. About the position ALS has an excellent opportunity for a Clinical Quality Assurance Specialist. The Clinical QA Specialist administers routine QA activities directly related to data, and final report, review and approval in the Clinical Department. The Clinical QA Specialist assists the Clinical Quality Assurance department and ALS QA Director on special projects. This position is based at our ALS Clinical office in Phoenix, AZ however some travel may be required to the other clinical sites (5-10% travel). This full time position will report directly to the Quality Assurance Director. 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.
Responsibilities
Shift: Full time, onsite, 40 hours a week, Monday to Friday - working hours 8:00 a.m. to 5:00 p.m. The successful candidate will be responsible for (but not limited to):
- Review of raw data and associated clinical reports for accuracy and compliance.
- Final report review and QA release.
- 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.
Qualifications
To be successful in the key role, you must demonstrate the following:
- Life Science Bachelor's Degree (Biology, Chemistry) Minimum of two (2) years of relevant experience in a clinical or quality-oriented role, preferably within an FDA regulated industry.
- Experience in GMP and GCP.
- Reliable with a strong commitment to quality.
- Multi-tasking and team player.
- Organized, detail oriented, competent, and responsible.
- Good technical writing and communication skills.
ALS offers a comprehensive benefits package that includes:
- Health Coverage: Medical, Dental, and Vision
- Retirement Plan: 401(k) and Roth contributions with a company match after 6 months of employment
- Paid Time Off, Vacation
- Company paid Life Insurance
- Company paid Short Term and Long Term Disability
- Other: Ancillary benefits
We would like to thank everyone for their interest in ALS but only candidates selected for an interview will be contacted. "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 Apply tot his job Apply To this Job