What are the responsibilities and job description for the QC Specialist position at CAI?
CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia. Experience in the pharmaceutical, medical device or biotechnology industries is required.
About CAI:
CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are You Ready?
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of 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.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents (employees) will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market, including COVID19 Vaccines and therapies. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
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.