QC Analyst Lead - Weekend Shift

Job Title:

QC Analyst Lead

Location:

Cambridge, ON (In-Office)
Position Type:
Full-time regular

Shift: Weekend Shift (Friday-Monday), 11:00pm-7:30pm
Vacancy Status:
This role will be vacant in October

AI Disclosure in Hiring:
Artificial intelligence (AI) may be used to assist with certain aspects of the recruitment process, including the initial review and screening of applications. Final hiring decisions are made by Human Resources and hiring managers.

Reporting to the QC NPI Supervisor, the QC Lead Weekend Shift is primarily a hands-on analytical role, conducting and supporting complex analytical testing and method transfer work. The remaining portion of the role carries weekend team leadership and quality coverage responsibilities, drawing from the QC NPI Supervisor and QC Supervisor functions.

The QC Lead conducts analytical testing of raw materials, in-process materials, finished products, stability samples, and packaging components, and supports method transfer, verification, and validation activities for new product launches. During weekend shifts, this role also provides working leadership to the QC laboratory team Chemical Analysts and QC Technicians ensuring compliance with cGMP, SOPs, and Bimeda quality standards, and serving as the point of contact for lab oversight in the absence of the QC NPI Supervisor.

Shift Availability :
Friday-Saturday-Sunday
-Monday : 10

Hrs.

• Conducts analytical (physical and chemical) testing of raw materials, in-process materials, finished products, stability samples, and packaging components using wet chemistry and chromatography instrumentation techniques.
• Conducts complex analytical testing utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF, and other laboratory instrumentation.
• Able to work directly from the USP or EP pharmacopeia to write protocols and execute methods; assesses, compares, and performs risk assessments for compendial method compliance according to USP, EP, and other applicable regulations.
• Verifies and processes analytical data for method transfer; writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, and method transfer protocols and reports.
• Supports NPI method transfer projects, working closely with R&D, QC Analysts, and the NPI team to meet product transfer timelines and quality requirements.
• Reviews laboratory documentation – notebooks, attachments, chromatography software, and specification sheets – for accuracy, completeness, and compliance with SOPs, specifications, and methods.
• Initiates deviations and investigations for applicable nonconformances; works with other departments and contributes to QC investigations to ensure accuracy and completeness of out-of-specification, out-of-trend, deviation, incident, and non-conformance events. Writes reports as required.
• Provides training, technical support, and expertise to QC Analysts, and supports department GMP compliance items as needed.
• Responsible for lab operations, safety, and schedules for the weekend team; supervises assignments and activity for Chemical Analysts and QC Technicians during the weekend shift.
• Collaborates with the QC NPI Supervisor and other internal departments on a regular basis to gain oversight of weekly manufacturing production and final release product planning, and assists in creating the test schedule for the QC team.
• Acts as the primary point of contact for laboratory investigations with internal and external auditors and regulatory inspectors during weekend shifts, in the absence of the QC NPI Supervisor.
• Ensures all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP/GLP), and Standard Operating Procedures (SOPs), escalating…