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Quality Systems Associate

Grifols Plasma Donation Center -
Saskatoon, SK

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Détails du poste

Permanent | Temps plein
45 760 $ par an

Profil recherché

Actions correctives en contrôle de la qualité
Utilisation d'un ordinateur
Soins infirmiers
Étiquetage
Investigation des déviations en contrôle de la qualité
Analyse de données
Actions correctives et préventives (CAPA)
Bonnes pratiques de fabrication (BPF)
Assurance qualité
Baccalauréat
Matériel informatique
Inspection de la qualité
Registres

Description complète du poste

About us

Grifols 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).

Grifols 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

Pay: $45,760.00 per year

Benefits:

Casual dress
Dental care
Disability insurance
Employee assistance program
Extended health care
Life insurance
On-site parking
Paid time off
Vision care

Application question(s):

Were you referred by a current employee of Grifols? If so, please indicate their name.
Are you available to work evenings and weekends?

Education:

Bachelor's Degree (required)

Work Location: In person

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