Quality Control

3 weeks ago

Cambridge, Canada Septodont Full time

**General information**:
**Reference **:2023-1570

**Position description**:
**Job Title**:
Quality Control - Chemist II

**Company Details**:
Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 2,000+ people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations have facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

Our Cambridge, Ontario site is also home to our Novocol Pharma division, which focuses on contract development and manufacturing, specialized in sterile injectable cartridge and combination product manufacturing.

Our employees are our number one asset We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

**Job Summary**:
Reporting to the QC Chemistry Manager, the Chemist II is responsible for chemical testing of raw materials, finished products and stability samples. As a technical Subject Matter Expert, the Chemist II is knowledgeable of all testing activities performed in the chemistry laboratory and responsible for training, investigations and problem-solving, documentation and tech transfer of analytical methods.

Please note the hours of work for this position are Monday to Friday 2:00pm to 10:00pm.

**Responsibilities**:

- Samples, tests and evaluates raw materials, stability and finished goods against both chemical and physical parameters defined in the product specifications, in a timely manner
- Effectively utilizes various laboratory equipment such as HPLC, LCMS, GC, Ion Chromatograph, ICP and Particle Size Analyzer in addition to wet chemistry techniques such as pH and titration
- Writes protocols, SOPs, test methods and final reports as required
- Reviews testing performed by other analysts for compliance to SOP’s and test methods
- Assists in conducting, DIR and OOS/OOT investigations.
- Participates in analytical method validations and method transfer
- Executes projects, QA Technical protocols and validation protocols as assigned, including calibration of chemistry equipment involved
- Provides support during internal and external audits as required
- Initiates CCRs to prepare specifications and develops new and/or updates SOPs
- Provides training for chemistry methodology and general chemistry techniques
- Follows GMP and regulatory requirements and ensures quality standards are met
- Demonstrates the company mission, vision and values statements, policies, and current standard business practices
- Observes and supports all safety guidelines and regulations
- Performs other related duties as assigned

**Qualifications**:
**Education**
- University degree in a related science (Chemistry)

**Experience**
- 3 years of working experience in the pharmaceutical industry or a related field
- Experience with LIMS and Empower is an asset
- Proven analytical and problem-solving skills with the ability to make recommendations
- Demonstrated organizational skills with the ability manage multiple priorities with mínimal direction
- Effective interpersonal and communication skills (verbal and written)
- Knowledge of Compendia, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and regulatory guidelines

**Contract type**:
Permanent

**Minimum level of education required**:
3- Bachelor

**Minimum level of experience required**:
2-5 years

**Languages**:
English (3- Advanced)

**Position location**:
**Job location**:
North America, Canada, Cambridge

**Location**:
25 Wolseley Court N1R 6X3 Cambridge

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