Quality Systems Associate

1 month ago

Regina, Canada Canadian Plasma Resources Full time

**About us**

Canadian Plasma Resources (CPR) is a pharmaceutical manufacturer licensed by Health Canada and certified by the European Union (EU) and the International Quality Plasma Program (IQPP). CPR is a source member of the Plasma Protein Therapeutics Association (PPTA).

CPR collects quality plasma from healthy donors. That plasma is used for further manufacturing into therapies to treat various health conditions.

**Position Summary**:
The Quality Systems Associate assists the Quality Systems Manager and is responsible for ensuring that all processes involving the collection, testing, processing, labelling, packaging, and storage of plasma adhere to the company's quality standards and the industry. They provide corrective/preventative action plans when such standards are not met.

**Position Objective**:
To provide confidence in processes, procedures, equipment and systems that work according to specifications and as expected.

Position Responsibilities:
1. Ensuring that all procedures related to producing a plasma unit comply with quality standards and regulations.

2. Managing all documentation related to quality, including standard operating procedures, policies, manuals, reports, test results and equipment logbooks.

3. Conducting internal audits of all Plasma Centers and designing an effective action plan if necessary, and arranging for external audits in the company.

4. Collecting and analyzing data for trend analysis (including deviation reports, exposure reports, and post-donation reports) and designing appropriate action plans to correct negative trends.

5. Collecting and analyzing data for epidemiological studies.

6. Validating and calibrating all equipment and instruments.

7. Inspecting incoming materials for defects and notifying the Plasma Centre Manager to reorder supplies.

8. Reviewing and revising written material/documents.

9. Maintaining a high level of working knowledge of national and international laws, regulations and standards

**Required Skills, Qualifications, and Experience**:
1. University degree in Science, Health Care or Nursing

2. At least 2 years of industry experience in quality control and quality assurance or equivalent recognized experience is an asset

3. Certificate in Quality Assurance Management or equivalent recognized certification is an asset

4. Proven ability to communicate and present effectively for training purposes

5. Proficient in usage and handling of computers and related peripherals

6. Working knowledge of Canadian Health laws, regulations, good manufacturing practice guidelines, and international regulations

7. Demonstrated analytical/problem-solving skills

**Job Types**: Full-time, Permanent

**Salary**: $41,600.00 per year

**Benefits**:

- Dental care
- Extended health care
- Paid time off
- Vision care

Day range:

- Holidays
- Monday to Friday
- Weekend availability

Shift:

- 8 hour shift
- Day shift
- Evenings
- Evening shift

COVID-19 considerations:
**Education**:

- Bachelor's Degree (required)

Work Location: One location

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