Quality Assurance Associate at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Life SciencesIndustries

Requirements

Tertiary education in a science or engineering-based field (e.g., biopharmaceuticals manufacture, biotechnology, process technology) or relevant industry experience
Post Graduate qualifications are beneficial
At least 3 years of experience in the pharmaceutical industry aligned to Quality Assurance
Excellent knowledge of cGMP
Desire to work in a highly dynamic, frequently changing environment with diverse perspectives
Strong written, verbal, and interpersonal communication skills
Strong ability to collaborate effectively and build rapport with internal and external collaborators
Good knowledge of Microsoft applications
Knowledge of SmartSheets is desirable
Continuous Improvement: Ability to challenge the status quo to improve outcomes
Adaptability: Ability to adapt to day-to-day business requirements
Collaborating: Skill in collaborating with diverse departments and colleagues
Customer Focus and Integrity: Dedication to delivering on promises made to customers
Commencing Activity: Proficiency in functioning solo and supervising prearranged assignments
Managing Relations: Ability to balance customer demands with business requirements and timelines
Quality Orientation: Ability to interpret and apply GMP principles, with strong attention to detail

Responsibilities

Furnish day-to-day aid within the Quality on the Floor Team, arranging, performing, and recording all duties
Efficiently fulfill responsibilities as part of the Quality Assurance department, positively impacting the site’s quality management system
Propel and back QA on the Floor team goals and objectives to synchronize with Quality and business strategies
Ensure manufacturing activities adhere to cGMP and standard operating procedures
Offer real-time quality support, including cGMP mentorship, document review, approval, and deviation handling
Review batch records within standard timelines required for batch disposition
Support continuous improvement (PPI) initiatives to realize cost savings and drive efficiency
Build effective working relationships with key internal collaborators to foster a collaborative work environment
Participate in and engage with Quality Management Review
Assist in regulatory and client audits, from readiness activities to direct engagement with auditors, ensuring successful inspection outcomes
Apply various risk assessment tools practically and advise others on their efficient application
Apply the Quality System daily, including Change Control, Deviations, CAPA, OOS/OOT, and Documentation Management
Carry out any other legitimate responsibilities as instructed by the Head of Quality Assurance or Site Quality Head

Skills

Key technologies and capabilities for this role

cGMPQuality Risk ManagementTrackWiseDocument ManagementDeviation ManagementBatch Record ReviewGMP MentorshipContinuous ImprovementRisk AssessmentRegulatory Audits

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Quality Assurance Associate role?

Candidates need tertiary education in a science or engineering-based field such as biopharmaceuticals manufacture, biotechnology, or process technology, or relevant industry experience, with at least 3 years in the pharmaceutical industry aligned to Quality Assurance. Post Graduate qualifications are beneficial, along with excellent knowledge of cGMP.

What is the work schedule and location for this position?

The employment is full-time with a flex schedule that includes on-call duty, based in Brisbane. Environmental conditions include adherence to GMP safety standards, cleanroom restrictions, office, and warehouse settings.

What soft skills are important for this role?

Strong written, verbal, and interpersonal communication skills are required, along with a strong ability to collaborate effectively and build rapport with internal and external collaborators. A desire to work in a highly dynamic, frequently changing environment with diverse perspectives is also key.

What is the salary or compensation for this position?

This information is not specified in the job description.

What makes a strong candidate for this Quality Assurance Associate position?

A strong candidate will have 3+ years of pharmaceutical QA experience, cGMP knowledge, tertiary science/engineering education, and excellent communication and collaboration skills to thrive in a dynamic environment while supporting quality systems and 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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