Qc (Quality Control) Supervisor
3 days ago
_Cliantha Research Inc._ is currently seeking a Full-time **QC Supervisor**; who can fulfill its business needs and is looking for better learning and growth opportunities.
**About Us**
Cliantha Research Inc. is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).
With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.
Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA (Florida & New Jersey), Canada (Mississauga, Winnipeg & Scarborough) & Europe (Portugal).
Roles and Responsibilities:
1) Assist the QC Manager in supervising work load, productivity and work quality of staff, ensuring assigned tasks are completed accurately and within defined performance expectations. Other duties include, but are not limited to:
i. Supervise performance and development of staff by providing coaching and feedback to staff regarding performance
ii. Provide training to QC staff, QC helpers and all other staff as required.
iii. Prepare and conduct performance appraisals for direct reports
iv. Process weekly payroll for direct reports
v. Ensure all QC Staff are logging time to projects per time logging process for project accountability
vi. Participate in hiring new employees for the department in conjunction with Human Resources staff and the QC Manager
vii. Assist QC Manager to complete weekly staffing schedules for the department
viii. Work closely with QC Manager to address staffing concerns, implementation of new ideas etc.
2) Assist the QC Manager in the development and implementation of QC processes and tools to ensure good quality study results. This may include, but is not limited to:
i. Development of QC and other company SOPs
ii. Development and implementation of QC plans as per Cliantha Research SOPs. Ensure that all required timelines are met.
iii. Represent the QC group as required at company meetings such as QA audit meetings, Site Initiation Visits, study meetings, etc.
iv. Work with the QC Manager, Clinical Operations management and study management staff to ensure all aspects of QC plans that outline the scope of quality control procedures are implemented, and ensuring QC processes are in alignment with Cliantha Research SOPs and study protocols
v. Development of QC checklists, QC shift reports and QC databases that are designed to document/track the QC review process
vi. Development of QC training materials/presentations
vii. Providing quality metrics to the Clinical Operations group as needed
viii. Review of study protocols and ICFs
3) Ensuring training file and SOP reading is maintained and up to date
4) Ensure compliance with appropriate Cliantha Research SOPs, GCP and ICH guidelines
5) Work in a safe manner that does not endanger yourself or co-workers
6) Strive to consistently uphold company’s core values
7) Execute other duties as may be required by the QC Manager and other members of management team as training and experience allow.
Any Additional responsibility given by Head of the Department / Management
Qualifications:
- Bachelor’s degree, with a minimum of three years of college, university, or technical school education in life science or relevant discipline.
- Ability to use computers and software associated to their job function (e.g. Microsoft Excel, Word and Outlook)
- Previous experience in a supervisory/management role is an asset
- Minimum 4-6 years of relevant QA/QC experience in a clinical or pre-clinical research setting; comparable relevant training and experience may be acceptable as assessed by Clinical Operations Management
- Good conflict management skills
- Displays an ability to identify, anticipate and define issues in a timely manner and to understand the potential impact of issues.
- Maintain a working knowledge of relevant US, Canadian and European GDP regulations as well as ICH regulations
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills
- Strong written and verbal communication skills
- Cliantha Research is committed to creating and maintaining a diverse, inclusive, and accessible environment for all its employees and clients. We value diversity at workplace and believe in fostering a spirit of excellence brought
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