Overview
We are seeking a highly skilled and detail-oriented Quality Control & Analytical Services Manager to oversee and enhance the quality assurance processes within our manufacturing operations. The ideal candidate will lead quality inspection activities, develop and implement quality management systems, has GMP and ensure compliance with industry standards. This role offers an opportunity to contribute to continuous improvement initiatives and uphold the highest standards of product quality.

Duties

- Manage and oversee all aspects of Quality Control laboratory, having technical oversight of the laboratory and analysts.
- Responsible for analytical testing of raw materials, in-process, and finished product testing
- Responsible for stability testing.
- Approving and releasing analytical results as per schedule.
- Author, review and approve SOPs, TMs, protocols, reports and other documentation Set up, qualification and troubleshooting of various analytical equipment as applicable.
- Setting up and generating specifications for raw material and drug products initiating change control for specifications with justifications where necessary.
- Responsible for maintenance of documentation, including laboratory notebooks, equipment log books and analytical data according to set standards.
- Review raw data of test results of in-process, finished and stability products as directed.
- Testing of raw materials, in-process, finished products, reference products and stability products as applicable.
- Generate test data for release of raw materials, in-process and finished products and stability products
- Generate test data for physico-chemical profiling of raw material, reference products and formulated products
- Generate preformulation and other test reports based on physico-chemical profiling.
- Perform scheduled equipment calibration and maintenance when due and as applicable
- Provide training to laboratory technicians and analysts
- Evaluate the purchase of laboratory equipment




- Handle special projects commensurate with qualification and experience as necessary
- Provide expert advice on analytical methods and procedures.
- Developing QC lab staff by training; maintaining regular discussions with direct reports; monitoring and appraising job results; providing coaching, counseling, mentoring and feedback to analysis; and monitoring compliance to SOPs, GMP and policies.
- Responsible for development and review of all laboratory operating procedures;
- Responsible for scheduling of testing and overseeing workflow to maintain productivity:
- Responsible for review of daily QC work and completing OOS investigations.
- Ensure compliance with cGMPs for the laboratory operations, interacting with QA, Product Development and Tech Transfer.
- Participate as a member of the team during on-site regulatory inspections to support compliance efforts and ensure successful audit outcomes
- Other duties assigned

Requirements

- Proven experience in pharmaceutical manufacturing, quality control, quality assurance, or related fields.
- Strong analysis skills with the ability to interpret data and make informed decisions.
- Expertise in quality management systems, QC processes, and project management methodologies.
- Knowledge of industry standards such as ISO 9001 or similar certifications is preferred.
- Excellent leadership skills with the ability to manage cross-functional teams effectively.
- Solid communication skills for reporting findings and collaborating with various departments.
- Experience in conducting quality inspections and implementing corrective actions.
- Bachelor's degree in Engineering, Manufacturing, Quality Management, or a related discipline is preferred. This position plays a vital role in maintaining product excellence and ensuring customer satisfaction through rigorous quality oversight.

Job Type: Full-time

Pay: $55,000.00-$75,000.00 per year

Ability to commute/relocate:

- Etobicoke, ON: reliably commute or plan to relocate before starting work (preferred)

Experience:

- Analytical chemistry: 3 years (preferred)

Work Location: In person

📌 Quality Control & Analytical Services Manager (Canada)
🏢 Pharmaceutical Manufacturing
📍 Canada