Overview

Baxter Quality Technician, CIVA Intern Full Time in Mississauga, ON

Baxter

Branch Mississauga ON CA

Position:
Quality Technician, CIVA Intern
Location:
Mississauga, ON

Prior QA experience in GMP licensed pharmaceutical industry. GMP related industry / Quality Operations / Pharmaceutical application / Compounding / Admixing….

Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.

SUMMARY OF RESPONSIBILITIES

Perform the quality functions at the Center for Intravenous Admixtures (CIVA) by providing support and guidance to ensure implementation of Quality Systems and compliance with pharmacy guidelines. Baxter Corporate Policies, SOP’s, applicable regulatory requirements and meeting customers’ requirements (internal & external customers). Monitor compliance through ongoing reviews and implement continuous improvements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Major Responsibilities / Activities

Perform the Quality Management review of admixtures batch of documentation for compliance with current procedures and conformance with Good Documentation Practices (GDP)

Identify non-conformances; timely escalate issues to Quality and CIVA Operations management as needed. Document and address non-conformance prior to providing release disposition

Perform sampling and inspection of admixes products disposition in a timely manner to meet internal and external customer requirements

ensure that admixes batch/es with associates CAPA/s is/are provided with disposition accordingly via the correction containment record in TW8 prior to completion of batch record review

update quality related metrics

Document/Record Management

Maintain organization of batch records

CAPA (Corrective and Preventive Actions) in Trackwise 8 (TW8)

Provide support for the timely initiation, investigation completion and closure of CAPAs in TW8 associated with in-process and/or admixed in products

Identify/Implement corrective and preventive actions and evaluate effectiveness

Complaints

Log and Track complaints

Coordinate the return of complaint samples, where applicable

Update complaint metrics

Reviewing/Inspection of Materials

Perform Quality inspection of materials upon receipt in the warehouse as needed

ensure that the suppliers, finished goods and materials with quality impact are approved in Global Supplier Quality Tracking System (GSQTS)

Hold Management and FCA

Coordinate with warehouse personnel the processing o finished goods, products or materials affected by holds and/or FCA’s following the current procedures

Management Review Meetings

Report the status of CIVA Quality Systems to the Manager of Quality, CIVA

Collect data/information for presentation to CIVA Quality Management Reviews

Training:
Ensure timely completion of required training

Other

Develop of revise SOP’s, as required

Participate in continuous improvement activities

Provide Quality support to various CIVA projects

Perform other Quality duties as assigned by the Manager, Quality CIVA or designate

Qualifications

Education/Experience

Education Level

Required:
Post Secondary education in Quality related discipline

Preferred:
University degree in related science

Registered Pharmacy Technician, license considered an asset

Major Subjects / Specialties

R

equired:
Science

Preferred:
Pharmacy, Chemistry, Biology

Type of Experience

Required:
1-2 Years of relevant work experience in GMP related industry / Quality Operations / Pharmaceutical application / Compounding / Admixing

Preferred:
3 or more years’ experience in

GMP related industry / Quality Operations / Pharmaceutical application / Compounding / Admixing

Prior QA experience in GMP licensed pharmaceutical industry

strong understanding of Health Canada GMP and Pharmacy Act General Regulation (O. Reg 202/94) Section IX Inspection of Drug Preparation Premises (DPP)

Additional Skills / Special Training / Technical Skills

Required:
Strong problem solving, critical thinking and analytical skills

Ability to prioritize multiple tasks

Knowledge and application of computer systems for word processing, reporting, data analysis, and complain management

Ability to proactively initiate and implement continuous quality improvement

Ability to work autonomously

Preferred:
GMP knowledge and experience

Lean or Six Sigma

Knowledge of parenteral products and their intended use

Process control orientation

Thank you for your interest and application to Baxter.

All applications will be reviewed and those candidates selected for consideration will be contacted directly.

Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Mississauga, ON, CA
Posted on: 2017-04-02
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