QA Officer at Thermo Fisher Scientific

Brisbane, Queensland, Australia

Apply Now

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

Process Validation

Equipment Validation

Cleaning Validation

Microbial Mapping

Deviation Investigations

CAPA

Change Control

SOP

Risk Assessments

Quality Management System

Audit Findings

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.

Land your dream remote job 3x faster with AI

Try Jobo Free