Title:  Senior Analyst, Quality Control

Job purpose

The main responsibility for this position is to perform method development, validation, verification and transfer activities to support Quality Control and Operations (Development).

Duties and responsibilities

• Development and Validation of test methods within the QC lab using HPLC, GC and other instrumental techniques with the goal of updating and improving existing methods
• Perform Assay, Impurities & Residual solvents method validation study.
• Prepare method validation, method verification and method transfer protocol and report.
• Perform assay, related substance and wet chemistry tests for bulk, in-process, cleaning swab solution & exhibit/stability sample.
• Support junior analysts for their troubleshooting in different analytical instrument and data analysis.
• Provide support in new Product Launch, Compendial Updates & Quality System
• Participate on projects in the area of focus related to process improvement
• Collaborate with other departments to proactively build quality into the processes and systems
• Creation and revisions to QC procedures as required
• Provide support for internal and regulatory inspections
• Identifies and implements key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements;
• Generate, gather and analyze data for reporting purposes;
• Complete all GMP documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Assist senior associate to complete OOS, OOT, CAPA, Lab Event & UPD in TrackWise.
• Initiate, and follow through with actions required to close Change Controls
• Other lab duties as assigned by the manager

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s Degree in Chemistry, or related discipline
• Minimum 6-8 years of Analytical method validation experience in the pharmaceutical Industry.
• Knowledge of Extractable & Leachable, Nitrosamine, IVRT, LCMSMS & GCMSMS would be an asset
• Demonstrate technical writing skills, leadership skills (including coaching and training)
• Expert knowledge and understanding of analytical chemistry and instrumentation
• Proficiency with analytical instrumentation (HPLC, GC, V-Vis, pH meter, viscometer, Karl Fisher apparatus, IR etc.)
• Knowledge of applicable software including LIMS, Empower and MS Office
• Sound knowledge and application of Health Canada and FDA regulations
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills
• Strong organizational skills and ability to multi-task; detail oriented
• Excellent problem solving and judgment skills
• Advance ability in investigative techniques to troubleshoot analytical problems

Working conditions

• Ability to work under stressful conditions and changing priorities
• Ability to support work in other shifts
• Numerous and varied responsibilities demanding attention and detail
• Working in general office and laboratory environments

Physical requirements

Office based role

Direct reports

• NA