Qa Compliance Associate 12 Month Contract
Cambridge, ON, Canada
Job Description
About the Role:
Reporting to the Quality Assurance Compliance Supervisor, the Quality Assurance Compliance Associate is directly involved in ensuring that the production & distribution of products meets quality standards by performing a detailed review of technical documents, monitoring and trending quality data, verifying product quality, resolving deviations, and ensuring timely approval and release of products as per GMP standards. The role includes coaching/training operators and supervisors on proper documentation practices on cGMP requirements, in-process documentation review and co-investigation of deviations to ensure real time, high quality investigations and accurate and rapid corrective action implementation.
What You Will Do:
The job posting is available in an accessible format upon request by contacting the Human Resources Manager Job Types: Full-time, Fixed term contract
Contract length: 12 months Salary: $40,000.00-$45,000.00 per year Work Location: In person
Reporting to the Quality Assurance Compliance Supervisor, the Quality Assurance Compliance Associate is directly involved in ensuring that the production & distribution of products meets quality standards by performing a detailed review of technical documents, monitoring and trending quality data, verifying product quality, resolving deviations, and ensuring timely approval and release of products as per GMP standards. The role includes coaching/training operators and supervisors on proper documentation practices on cGMP requirements, in-process documentation review and co-investigation of deviations to ensure real time, high quality investigations and accurate and rapid corrective action implementation.
What You Will Do:
- Assesses potential impact of incidents and deviations on the quality and suitability of the product for sale. Includes conducting in-process batch record review and determining batch status, e.g. release, reject or product hold for further clarification or investigation.
- Performs internal QA audits on manufacturing lines and finished products to ensure that they are compliant with corporate policies, practices, and procedures.
- Provides oversight and QA approval to various systems (CAPA, Deviation) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed.
- Investigates both individually and as a team member, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
- Monitors QA systems and advises/presents to management team on system performance; publishing metrics/reports regarding performance against set goals.
- Provides support to other functions of Quality Assurance department which includes but not limited to the preparation of master documents and the coordination of documentation services through other departments.
- Promotes and advocates quality achievement and performance improvement across the organization.
- Participates as required in Health Canada, FDA & customer audits and ensures corrective actions are completed with customer specifications or SOPs.
- Ensures ongoing compliance with local, national, and international standards and legislation.
- Other duties as assigned.
- 2-3 years? relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control.
- BSc degree in science or related field, QA courses or training.
- Knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry.
- High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative.
- Flexibility to work different shifts and on weekends.
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Medical, Dental, Vision Benefits
- Defined Contribution Pension plan with employer matching
- Employee Assistance Program
The job posting is available in an accessible format upon request by contacting the Human Resources Manager Job Types: Full-time, Fixed term contract
Contract length: 12 months Salary: $40,000.00-$45,000.00 per year Work Location: In person
Beware of fraud agents! do not pay money to get a job
MNCJobz.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.
Related Jobs
Job Detail
-
Job IdJD2170934
-
IndustryNot mentioned
-
Total Positions1
-
Job Type:Full Time
-
Salary:Not mentioned
-
Employment StatusPermanent
-
Job LocationCambridge, ON, Canada
-
EducationNot mentioned