CAI

Operational readiness consulting for pharma

Quality Control Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeMelbourne VIC, AustraliaNo salary listedIn-person

About the Job

Requirements

Prior hands-on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory environment.
Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
Understanding of Good Manufacturing Practice and Good Laboratory Practice requirements and regulatory expectations related to quality control.
Ability to work autonomously and adapt to a fast-moving, start-up-style environment.

Responsibilities

Assist with the setup and operationalization of the new quality-control laboratory.
Lead or support the transfer, validation, and qualification of analytical methods for internal use.
Implement robust procedures for method documentation and compliance.
Perform quality testing of incoming raw materials to ensure conformance with specifications.
Conduct in-process quality assessments to support manufacturing and scale-up activities.
Execute and document final product testing to support batch release.
Investigate out-of-specification results or quality deviations in coordination with Quality Assurance.
Maintain high standards of Good Manufacturing Practice documentation and record-keeping.
Support the development of Standard Operating Procedures, forms, and test records.
Assist with audits, internal inspections, and continuous-improvement initiatives.

Desired Qualifications

Experience with method transfers and laboratory setup is highly desirable.
Strong attention to detail, organization, and problem-solving skills.

CAI Overview
Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:
• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:
• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Requirements include:

Position Description:

Assist with the setup and operationalization of the new QC laboratory.
Lead or support the transfer, validation, and qualification of analytical methods for internal use.
Implement robust procedures for method documentation and compliance.
Perform quality testing of incoming raw materials to ensure conformance with specifications.
Conduct in-process quality assessments to support manufacturing and scale-up activities.
Execute and document final product testing to support batch release.
Investigate any out-of-specification results or quality deviations in coordination with QA.
Maintain high standards of GMP documentation and record-keeping.
Support the development of Standard Operating Procedures (SOPs), forms, and test records.
Assist with audits, internal inspections, and continuous improvement initiatives.

Requirement:

Prior hands-on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory environment.
Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
Experience with method transfers and laboratory setup is highly desirable.
Understanding of GMP/GLP and regulatory expectations related to QC.
Excellent attention to detail, organization, and problem-solving skills.
Ability to work autonomously and adapt to a fast-moving, start-up style environment.

About the Company

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size: 1,001-5,000
Company stage: Pre-seed
Total funding: $3.4M
Headquarters: Indianapolis, IN
Founded: 1996

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