Supervisor, Quality, Logistics and Operations Support at Thermo Fisher Scientific

Newcastle, New South Wales, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, ManufacturingIndustries

Requirements

Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Compliance with Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc
Ability to work in Laboratory Setting, Office, and Warehouse environments
Willingness to wear some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Knowledge of cGMP/ISO principles, company policies and procedures
Familiarity with root cause analysis tools
Understanding of local and international regulations for importing/exporting products, including non-edible meat products
Awareness of Department of Agriculture Forestry and Fisheries (DAFF) and Australian Customs requirements
Knowledge of SafeWork NSW legislation and company WHS procedures and policies
Familiarity with Practical Process Improvement (PPI) tools

Responsibilities

Ensure all quality assurance and quality control tasks on site (documentation, environmental monitoring, deviation and change control) are completed aligned with cGMP/ISO principles, company policies and procedures
Complete quality documentation review and ERP release of production components, raw materials and final product at the Newcastle site
Lead the receipt and export of raw serum quality samples to Auckland for quality control testing
Lead on-time revision of quality documents (SOPs, standard forms, batch manufacturing records)
Support training on site
Ensure deviations, non-conformances, customer complaints and internal audits are investigated in compliance with procedures, using root cause analysis
In conjunction with Production Supervisor, be accountable for aseptic cleanroom operational activities (staff training, rostering, setup, dispensing, monitoring, sampling, testing, segregation)
Ensure environmental monitoring activities and media fill reads are performed, reviewed and processed independently of production
Lead and co-ordinate regulatory and customer audits for the site
Support supplier audit management programs on and off site
Work with third party transport providers to arrange shipping of raw materials, semi-finished and finished goods domestically and internationally, following regulations and procedures
Stay informed about regulatory requirements for importing/exporting from Australia to diverse markets
Produce regulatory documentation for import/export of non-edible meat products
Maintain records of export documentation in compliance with DAFF, Australian Customs and company requirements
Act as Subject Matter Authority for import/export processes and documentation within the team and region
Support inventory accuracy initiatives
Follow SafeWork NSW legislation and company WHS procedures, report hazards, provide input into resolutions
Assure operations align with government and company legal requirements
Ensure colleagues and visitors comply with safety requirements and follow safe work practices
Support leadership initiatives to enhance safety culture
Promote continuous process improvement initiatives through applying PPI tools and training colleagues

Skills

cGMP

ISO

Quality Assurance

Quality Control

Environmental Monitoring

Deviation Management

Change Control

Root Cause Analysis

ERP

Supply Chain

Procurement

Aseptic Processing

GMP Documentation

SOP Revision

Internal Audits

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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