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Job Summary
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 weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were 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.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
IC
CAI OverviewAre You ReadyCAI 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 r...
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 weve challenged ourselves to do what others wouldnt. 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 isnt simply a goal. Its 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. Were not interested in how it used to be done. Were 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.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
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