Job Description

PRIMARY RESPONSIBILITY Develop and maintain the Quality Control Instruments Qualification/Requalification/PM Program, providing onsite support for troubleshooting of instrumentation used in the QC Laboratory. SPECIFIC DUTIES

• To ensure that all laboratory equipment/instruments used for testing and release of products are qualified in accordance with Trillium requirements and as applicable industry standards for laboratory instrument qualification.
• Manage Qualification/validation of QC Lab equipment/instruments (new and existing)
• Manage the decommissioning of laboratory equipment using the Change Management Process.
• Request Trillium New Asset Number for Equipment/System and request and assign the Protocol Number
• Initiation and ownership of the change control and all related impacts identified for introduction of instrument or modification of instruments as required.
• To follow up with any change management requests that may require partial or full qualification and to consult with the appropriate QC personnel to determine the extent of qualification required.
• To perform a risk assessment and determine the extent of validation activities required
• Initiate/revise appropriate Standard Operating Procedures related to validation activities as required
• Coordinate with vendor for PM/Certification/Repair Quotes, scheduling of visits, if not able to be managed onsite.
• Work and coordinate with Trillium Finance department for PO generation and vendor invoices review.
• Schedule/Coordinate the execution of the IQ, OQ, PQ testing with the responsible parties (vendor technician, Equipment Qualification Specialist, QC Analyst, Trillium Maintenance department, QC Supervisor, QC Manager).
• Execute and assist the vendor technician representative in the execution process of the qualification protocol in compliance with Trillium\xe2\x80\x99s documentation requirements, Good Manufacturing Practices (GMPs) and standard operating procedures.
• Ensure that all calibration, maintenance and performance monitoring documents have been documented and record the references of test equipment and materials with associated calibration information.
• Ensure that where multiple modules are combined to create a system (e.g. HPLC, GC, and Dissolution Tester), whole system testing has been performed to complete qualification/validation.
• Write and assist the vendor in writing deviation report for tests that do not meet the qualification requirements, which will include recommended actions and actions taken.
• Work with QC Analyst, QC Supervisor, QC Manager, QA Manager, and QA Supervisor to ensure the changes are reviewed and approved prior to use.
• Coordinate validation activities with other departments to ensure all aspects of the protocol are completed and reported as required.
• Obtain any required documentation from vendor/concerned departments involved in execution to complete qualification packages, if necessary.
• Check that each required stage of the qualification/validation has been satisfactorily completed and approved.
• Work with IT department to ensure instrumentation is set up and maintained according to CFR 21 Part 11 compliance (e.g., user privileges, windows security settings, backup and recovery of the software).
• Management of Qualification/Requalification validation schedules and supporting documentation.
• Support all routine troubleshooting support related to laboratory instrumentation, Sampling Quality Control, Chemistry, Chromatography and Microbiology
• Perform verification activities for chemistry and chromatography instruments as required by Trillium\xe2\x80\x99s SOP in absence of analysts (e.g., dissolution baths, UV, RI, balances, TOC meters)
• Work with Vendors in creating new methods on an existing and newly qualified instrument
• Train analysts on a newly qualified instrument
• Perform all work within safety guidelines and maintain order and cleanliness of the work area.
• Other duties as assigned.

EDUCATION/EXPERIENCE

• A BSc or 3 year College Diploma in Science related discipline.
• Knowledge and training in regards to usage, troubleshooting and maintenance on the following lab equipment brands would be considered an asset: WATERS HPLC, Agilent GC, Mettler Toldedo and Perkin Elmer.
• Knowledge of Data integrity and Qualification requirements in GMP environment
• Strong project management and organizational skills

Job Types: Full-time, Permanent Salary: $65,000.00-$70,000.00 per year Benefits:

• Company pension
• Dental care
• Employee assistance program
• Extended health care
• Profit sharing

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Overtime pay

Ability to commute/relocate:

• BROCKVILLE, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

• Have you ever been charged with a criminal offence which you have not received pardon?

Work Location: One location