QA Officer at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent)
At least 3 years of experience in a GMP regulated setting
Ideally, at least 1 year of experience in Quality Assurance within a GMP-regulated setting
Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines
Strong communication skills
Strong written, verbal and presentation skills
Adhere to EHS policies and procedures and ensure a safe and healthy workplace environment
Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported
Not knowingly pollute the environment

Responsibilities

Reviewing and approving Process Validation / Equipment Validation documents promptly, including Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc
Active participant in deviation investigations
QA Approval of quality records including but not limited to; Deviations, CAPAs, Audit findings etc
Reviewing and endorsing QA controlled documents within the Quality Management System
Supports compliance to systems timeframes for raising, processing or performing associated tasks (i.e. Change Control actions, DR investigations, processing CAPAs)
Issuing protocols as required to other departments
Updating SOPs and other documents to meet current regulatory and corporate standards
Serving as a resource to the operational areas on quality-related issues
Identification of continual improvement opportunities
Participating in Risk Assessments
Any other legitimate duties requested by QA Manager

Skills

Key technologies and capabilities for this role

Process ValidationEquipment ValidationCleaning ValidationMicrobial MappingDeviation InvestigationsCAPAChange ControlSOPRisk AssessmentsQuality Management SystemAudit Findings

Questions & Answers

Common questions about this position

What qualifications and experience are required for the QA Officer role?

Candidates need a tertiary academic level in a relevant field such as Biotechnology, Biochemistry, Microbiology, Chemistry, or Pharmacology, at least 3 years of experience in a GMP regulated setting, and ideally 1 year in Quality Assurance within a GMP-regulated setting.

What are the key skills needed for this position?

The role requires knowledge of pharmaceutical cGMP quality systems and international regulations, along with strong communication, written, verbal, and presentation skills.

Where is the QA Officer position located?

The position is located in Brisbane, Australia, with a standard Monday-Friday office work schedule.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for the QA Officer position?

A strong candidate has a relevant tertiary degree, 3+ years in GMP environments with QA experience, knowledge of cGMP systems, and strong communication skills to support validation, deviations, and compliance tasks.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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