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Pharmaceutical, Quality Assurance Analyst Ii

2 weeks ago

Delta, Canada Phyton Biotech Full time

Phyton Biotech is a GMP manufacturer of active pharmaceutical ingredients (API’s) for the world-wide market. As the world’s leading provider of “green” Plant Cell Fermentation (PCF®) Technology, Phyton Biotech produces paclitaxel and docetaxel APIs and offers comprehensive development and manufacturing services of other plant-based molecules, extracts, and recombinant products for use in the Pharmaceutical, Traditional Chinese Medicine (TCM), Cosmetic, Agricultural and Food Ingredient industries.

Phyton’s cGMP certified facility in Canada specializes in the purification and chemical conversion of natural active ingredients, improving the quality of life for patients and consumers while respecting our environment. With more than 25 years experience in product/process development, production, and commercialization, we manufacture safe, reliable, and high-value APIs for customers around the world. Our site has the capacity to meet more than ⅓ of global demand for paclitaxel and docetaxel, commonly used active pharmaceutical ingredients (API’s) in chemotherapy medications and medical devices.

Phyton Biotech is also involved in process development and production of pre-clinical and clinical materials.

Phyton Biotech is adding to its Pharmaceutical Quality Assurance Department. This team supports the manufacturing of Phyton Biotech’s API’s and Intermediates at development and commercial scale which meet cGMP and Phyton’s quality and safety requirements, while supporting customers and regulatory authorities.

**What Phyton Biotech will offer you**:
Phyton Biotech determines an individual’s pay based on multiple factors including experience, education, job-related skills, and equity within the team or organization. The compensation range for this role is $61,000 - $68,000.

We encourage a progressive team environment with a work home balance by offering an innovative organization wide schedule of 9-day work rotation every two weeks, to afford our employees with additional rotational time off to spend with family.

**We are eager to connect with you, if**:

- You have pharmaceutical quality assurance experience
- You are detail-oriented with an eye for quality and accuracy
- You have strong analytical skills, with capability to evaluate information, and make appropriate decisions in response to challenges
- You thrive in collaborative environments with strong interpersonal skills, but comfortable working autonomously
- You thrive on multi-tasking, working in a fast-paced environment and are driven to solve problems and improve processes

**A day in the department would include**:

- Assist with ensuring Phyton’s quality system remains compliant with regulatory requirements and industry standards
- Supports the continuous improvement of the quality system and procedures to maximize efficiencies and safety, and minimize deviations/incidents/investigations
- Provides quality support and guidance for internal departments
- Manage a quality system element
- Performs reviews of quality documents, such as SOPs, test methods, non-conformances, OOS’s/OOT’s, CAPAs, change controls, incidents, Certificates of Analysis, protocols, reports and risk assessments
- Performs reviews of QC, Operations, Logistics and Engineering quality records, such as analytical data, completed batch records, completed forms, executed qualification/validation protocols and reports
- Perform document control activities
- Assist with internal, customer and regulatory audits

**Qualifications & Experience**:

- BSc in a life-sciences, chemistry/biochemistry or related discipline required
- Minimum of 3 years quality assurance experience in a pharmaceutical, biopharmaceutical/biotech industry
- Knowledge of a Quality Management Systems (QMS) is required

**Job Types**: Full-time, Fixed term contract
Contract length: 12 months

Pay: $61,000.00-$68,000.00 per hour

Expected hours: 40 per week

Additional pay:

- Overtime pay

**Benefits**:

- Casual dress
- Company events
- On-site parking

Schedule:

- Day shift
- Monday to Friday

Work Location: In person

Expected start date: 2025-07-21