The Quality Assurance Specialist provides supervisory and management support to QA management as required. As an integral member of the Cetero Research Quality Assurance Department, the QA Specialist performs routine audits and inspections of projects and processes in the clinical, pre-clinical, scientific affairs and/or bioanalytical areas; as well as performs non-routine audits, such as audits of vendors, internal processes, systems, facilities and validation projects. The QA Specialist also assists the site QA management in conducting investigations, in providing clarification and follow-up on various quality metrics, and in hosting sponsor audits and regulatory inspections. The QA Specialist may also conduct training on QA processes and regulatory and other topics, in coordination with the Cetero Research and or site training coordinator. The QA Specialist is expected to analyze and evaluate data to determine compliance with the study protocol, Cetero Research polices and procedures, and applicable regulations and guidelines; to inform site and QA management of any observed issues identified during the conduct of audits; and to provide guidance as needed to staff to address the required corrective or preventive measures.
JOB INTERACTIONS AND INTERFACE:
This position primarily interacts internally with all levels of staff, and may occasionally interact with external sponsors, vendors and regulatory inspectors.
Prepare and conduct routine audits of Clinical/Pre-clinical/Scientific Affairs/ Bioanalytical projects conducted at the site as scheduled. These audits are intended to assess Cetero sites compliance with Good Regulated Practices (GxP), Cetero Quality System Documents (such as standards, SOPs, WIs), study protocols, pertinent industry regulations and guidelines; they include, but are not limited to, the following:
Review protocols, informed consent forms, source document templates/logs and other project-specific documentation not otherwise reviewed formally in an audit.
- pre-study (documentation) audits
- in-process (procedures and documentation) audits
- post-study (documentation) audits
- data management
- statistics and/or pharmacokinetics
- clinical/bioanalytical study reports
- validation reports
Prepare and conduct routine process/system audits, as well as audits of validation and/or qualification of computerized systems and facilities.
Prepare and conduct qualification surveys and/or audits of 3rd party vendors that provide goods and/or services that support GxP activities at Cetero Research.
Keep QA Management up to date with findings and follow up on corrective actions.
Analyze and evaluate available data and prepare written Audit Reports of findings and observations to be shared with site and senior management as required.
Perform adequate and timely follow-up of audits, and issue Quality Assurance statements/certificates for audits conducted.
Create Quality Plans, Audit Plans or Audit Checklists for assigned projects.
Coordinate with site QA management in the submission and effective maintenance of quality-related data for the development and tracking of quality metrics.
Coordinate with Cetero Research and/or site training coordinator in conducting training on QA, regulatory compliance and other related topics.
Perform root cause analysis, CAPA investigations and other QA investigations.
Assist in the hosting of sponsor representatives (monitors, auditors, etc.), IRB personnel and regulatory (e.g. FDA, EMA, HC) inspectors.
Assist the site and QA management in the identification of quality process improvement opportunities and in the development of new processes, documentation and other tools.
Work with the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures as required.
Ensure compliance with appropriate Cetero SOPs, GCP (&/or GLP if applicable) and ICH guidelines.
Ensure personal resume (CV) is updated annually as required.
Keep personal training file updated on a regular basis.
Participate in training sessions.
Work in a safe manner that does not endanger yourself or co-workers.
Strive to consistently uphold Ceteros core values.
Execute other duties as may be required by QA Management and other members of Cetero Research Management team as training and experience allow.
WORKING CONDITIONS AND ENVIRONMENT:
Work is normally performed in a typical office work environment as well as in a clinical and/or laboratory setting.
This role will require considerable amount of time seated and spent on the computer and reviewing information on both electronic and paper media.
Moderate physical activity is expected from this role, including handling of average weight objects up to 25 lbs., such as large binders and study files, or standing and walking for more than four hours during audits.
This role involves working in an environment where there is a potential for exposure to bodily fluids, chemical substances, fumes, allergens, etc. while performing audits, which require following basic safety precautions.
This role will require the flexibility to work a variety of shifts based on work load within the site, including: days, evenings and weekends.
SKILLS AND QUALIFICATIONS:
Minimum of Bachelor of Arts or Science Degree in a related field or sufficient equivalent relevant training and experience as judged by the site QA management.
Received industry certification in Quality or Clinical Research (e.g., RQAP-GxP, CQA, CCRC, CCRA, CCRP, etc.) is an asset.
A minimum of seven years experience in a Quality role in the clinical and/or pre-clinical research industry.
Expert knowledge of, and remaining current with, regulatory requirements pertaining to clinical and/or pre-clinical research (HPFB, FDA, EMA, MHRA, as well as GCP, GxP, etc.).
Extensive experience in quality review (QC/audit) of documents, processes and systems in various phases of clinical/pre-clinical trials that will enable only minimal training on the clinical/bioanalytical audit program at Cetero Research.
Extensive experience in audits of computer system validation and third party vendors.
Experienced knowledge in root cause analysis and CAPA investigations.
Attention to detail and the ability to spot inconsistencies a must.
Executes job responsibilities with very minimal supervision; instead, provides some degree of supervision/mentorship to other staff.
Ability to understand and follow basic scientific research protocol and procedure.
Well-developed analytical and problem solving skills, and have the ability to analyze and interpret scientific data. Proactively identifies problems and helps others with problem solving.
Decisive, good decision making skills, able to provide leadership to others in response to situations and to escalate more critical decisions when relevant
Very organized and able to multi-task.
Excellent verbal and written communication skills.
Highly effective interpersonal, customer service and conflict resolution skills.
Advanced proficiency in the use of personal computers and relevant software applications.