Laboratory Systems Associate

**Job Task**

Establishes, develops, executes and completes installation records, qualification protocols and validation documentation.
- Performs direct installation activities, such as creation, execution and completion of installation records.
- Performs direct qualification activities, such as creation, execution and completion of qualification protocol (QMP, DQ/UR, IO, OQ, PQ and QSR).
- Performs direct validation activities, such as creation, execution and completion of validation documentation (Validation plan, System Overview, Design Specifications, requirements, traceability matrix, Test Plan, Test cases, validation report, etc.) and supporting documents (i.e. Data Flow Diagrams).
- Conducts validation or qualification tests of new or existing processes, equipment, or software, in accordance with internal protocols and where applicable, external standards.
- Conducts routine review of validation or qualification documentation and processes to ensure compliance with internal or regulatory requirements.
- Liaises with external parties on equipment and consumables. This can include quotation request, management of service/maintenance contracts/agreements, repairs and disposal.
- Liaises with internal parties for equipment preventive/corrective maintenance, calibration arrangements, installation, qualification and validation protocol review and approval, purchase orders and vendor invoice requires. This includes:

- Maintaining equipment calibration, preventive/corrective maintenance records.
- Ensuring timely calibration and/or preventive maintenance of equipment.
- Creating and maintaining databases for tracking equipment calibration, preventive/corrective maintenance.
- Generation and maintenance of equipment list for clinical research studies.
- Maintains the Master Equipment list.
- Tracks equipment issues/problems via an appropriate change control and problem management system.
- Tracks equipment/system changes including but not limited to configuration change, access review or documentation update via an appropriate change and problem management system.
- Creates and maintains database for qualifications, validation activities, test results, or validated systems.
- Plans and projects new equipment needs and old equipment replacement and retirement.

**Data Management and Quality Control**
- Performs entry and verification of data in laboratory systems and equipment.
- Ensures quality control processes are adhered to and maintained.
- Ensures asset protection.
- Liaises with IT and CRU personnel for any IT related equipment and system needs.
- Ensures activities are in compliance with internal and regulatory requirements.

**Regulatory Compliance**
- Ensures good documentation practices are met.
- Familiar with CSQ policies, procedures, SOPs and regulatory requirements for laboratory systems and equipment.

**People**
- Orientates, train and coach new CRU personnel on equipment handling and operations.
- Acts as a technical resource within the CRU.
- Contributes to a positive work environment by demonstrating excellent interpersonal and communication skills.
- Actively participates in individual performance management plan and yearly performance and developmental planning to support corporate priorities and business goals.

**REQUIRED QUALIFICATIONS AND EXPERIENCE**
- Diploma or Degree in Life Sciences, Engineering, Information Systems or Computer Systems.
- Preferable with biomedical and/or clinical research experience.

**REQUIRED SKILLS**
- Good communication, time management and interpersonal skills.
- Flexibility in work outlook.
- Computer literate.
- Ability to work independently.