Quality Control Analyst

2 weeks ago


PointeClaire, Canada Capcium Full time

Version française à suivre_

**About Capcium**

We are an innovative, fully licensed value-add service platform provider for customers in the Pharmaceutical, Over the Counter and Health & Wellness industries. Capcium has developed a best-in-class team of softgel encapsulation professionals leveraging decades of manufacturing expertise, customer support experience and formulation customization knowledge from leading softgel manufacturers. We are dedicated to delivering the best customer experience and providing quality products while keeping our core values at the heart of everything we do.

**Why work at Capcium**

We are a continuously growing company offering a unique opportunity to learn and be apart of a dynamic team. While ensuring high-quality service throughout every point in the journey, we strive for open and honest communication to create strong relationships between employees and customers. We foster a collaborative environment to ensure a drive towards shared goals and success. Our foundation is based on integrity and agility, ensuring trust amongst coworkers and quick responses to rapid changes in the internal and external environments.

**Overview**

Under the supervision of the QC Manager, the QC Analyst is responsible for performing analytical tests in daily laboratory operations and execution of testing to support manufacturing operations. Testing typically includes samples from raw materials, in-process intermediates, final drug product manufacturing, stability and various development studies using approved test methods. This position requires understanding and ability to perform techniques such as HPLC, HPLC-MS, GC-FID, GC-MS, ICP-MS, UV-VIS, FTIR and Wet Chemistry. All work is executed following cGMP guidelines and Corporate SOP’s.

**Main Responsibilities**
- Conducts analytical testing of routine samples (raw material, in-process, and finished product) using instrumentation (80-90%) and wet Chemistry (10-20%) techniques.
- Performs all work activities in a safe manner and in compliance with applicable Health and Safety Regulations.
- Ensures that all work is performed in compliance with GMPs, GLPs, SOPs, and other established regulatory requirements.
- Independently or under supervision operates analytical instrumentation like HPLC, GC, GC-MS, LC-MS, ICP-MS.
- Participate in analytical methods verification and validation.
- Able to follow planning and to complete the workload in a timely manner.
- Clearly and efficiently documents test results, calculations, and observations as per the established SOPs.
- Recognizes OOS, out of trend and anomalous results and inform the supervisor or delegate immediately.
- Performs general maintenance and calibration of laboratory equipment, according to the department’s established calibration program, when assigned.
- Performs additional related duties, as assigned by Management.
- Back-up for this role is the Quality Control Manager, Chemistry.

**Qualifications**
- A University degree in analytical chemistry or organic chemistry. Post-Secondary education in a science field with work experience will be considered.
- 1+ years related QC work experience in a pharmaceutical laboratory using GC and HPLC instrumentation. Experience with GC-MS, LC-MS, ICP-MS is a strong asset.
- Able to rigorously apply, follow and maintain rules, procedures, and processes.
- Ability to follow written procedures with close attention to detail and high level of accountability.
- Be proactive and resourceful to help prevent and solve problems.
- Must be able to multi-task and to work independently and as part of a team.
- French and English language proficiency.


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