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 Plasma Protein Therapeutics Association (PPTA). CPR collects quality plasma from healthy donors. That plasma is used for further manufacturing into therapies to treat a variety of 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, labeling, packaging, and storage of plasma adhere to quality standards of the company 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 they are working according to specifications and as expected Position Responsibilities: 1. Ensuring that all procedures related to the production of 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:
Casual dress
Dental care
Disability insurance
Extended health care
Life insurance
Paid time off
Vision care
Schedule:
8 hour shift
Day shift
Evening shift
Holidays
Monday to Friday
Weekend availability
COVID-19 considerations: All candidates should be fully vaccinated. Ability to commute/relocate:
FREDERICTON, NB: reliably commute or plan to relocate before starting work (required)
Application question(s):
Were you referred to this role by a current employee of Canadian Plasma Resources? If so, please indicate their name.
Education:
Bachelor\'s Degree (required)
Work Location: One location
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