QA Assistant

6 months ago

Melbourne, Australia AmerisourceBergen Full time

**What you will be doing**:
***:
Under general direction of the Local Quality Manager plays an important role supporting all quality processes for the Clinical Trial and Transport divisions including quality assurance tasks and quality control checks. Provides support to office and Clinical Trial/Commercial/Transport associates on all matters pertaining to quality and compliance.

**PRIMARY DUTIES AND RESPONSIBILITIES**:

- To follow Quality Assurance Policies and Procedures, supporting the implementation of Quality Assurance Standards.
- Collaborate with the local Quality team in all quality related processes such as change control, external/internal audits, risk assessments, Quality Agreements, etc.
- To participate in the CAPA and complaint process, including collaborating in the investigation, support with the generation of reports, and tracking deviations and actions as described on the specific internal guidelines.
- Assist the local Quality team in managing documentation and training program including but not limited to maintenance of local training matrix.
- Assist the local Quality team in maintaining all applicable documentation properly filled and up to date either electronic or paper based.
- Assist with the Suppliers Evaluation program (i.e., coordinate self-assessments responses, follow up on pending information, etc.).
- Support the translation of internal guidelines and the creation/revision and control of local policies, SOPs, and Work Instructions.
- Assist with temperature mapping, calibration, maintenance, and qualification program according to internal guidelines.
- Assist with the preparation of local KPIs Assist in the organization of any quality related training.
- Support the quality team in performing Quality spot checks on inbound, outbound, return and labelling and secondary processes.
- Assist with quality related activities related to the Self-Inspection Report.
- To support any changes/developments initiated by Local Quality Management.
- Perform any other duties in which the employee has been trained.

**SECONDARY DUTIES**:

- Support and / or generate and assess training compliance reports for the local team.
- Support and / or maintaining local training matrix.

**What your background should look like**:
**EXPERIENCE AND EDUCATIONAL REQUIREMENTS**:

- Tertiary level education (at least as student) in one of the following disciplines: pharmacy, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology, logistics and related fields.
- Basic understanding of Quality Management processes (e.g., ISO 9001).
- GMP experience preferred.
- Ability to prepare routine administrative paperwork.
- Experience in database management systems, electronic Quality Management systems.

**REPORTS DIRECTLY TO**:

- Local Quality Manager

**MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS**:

- Full Command of English Language: Written and Oral Skills.
- Able to take on the rostered hours from Mon to Thurs; 9AM to 2PM OR Mon & Tues; Full day and Wed; Part day.
- Excellent interpersonal relationship and communication skills.
- To be extremely accurate and organized.
- Be able to take initiatives and responsibilities.
- Open minded.
- Advanced skills in Microsoft Office specifically in Excel, Word and PowerPoint).

**WORK ENVIRONMENT**:
The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

**What AmerisourceBergen offers**:
We offer a competitive total rewards package which includes benefits and compensation. Our commitment to our eligible population of team members includes benefit programs that are comprehensive, affordable, diverse, and designed to meet the needs of our team members’ and their families. Some of these programs include paid time off including paid parental leave, access to retirement savings vehicles, medical, dental, vision, and life insurance options, an employee stock purchase program, and other financial, health, and well-being focused benefits.

**Schedule**:
Part time

**Affiliated Companies**: Affiliated Companies: World Courier (Aust) Pty. Ltd

**Equal Employment Opportunity**:
AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

**EXPERIENCE AND EDUCATIONAL REQUIREMENTS**:

- Tertia

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