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Quality Control Analyst II, HPLC

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Control Group Leader within the Research Products/ISO department based onsite in our Andover, MA facility.  CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets.  CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.

Our employees are active contributors to the company’s success and enjoy long term careers at CIL. Over 95% of CIL’s senior managers have been with the company for more than 15 years. CIL employees appreciate the small company atmosphere and the value of employee contributions, team camaraderie and excellent benefits package.

Under the general supervision of a group leader, the Quality Control Analyst II will perform various analytical techniques to determine isotopic enrichment, chemical purity, concentration and identity testing on a wide array of stable isotope-labeled materials (13C, 15N, Deuterium, and 18O isotopes). The incumbent will focus primarily on HPLC analyses of solutions and neat materials, in support of our production chemists, Supply Chain group and ISO 17034 reference materials program.

Responsibilities

  • Responsible for performing routine analyses utilizing primarily HPLC analytical techniques. May perform other analytical techniques such as NMR, GC, and wet chemistry
  • Responsible for troubleshooting basic issues with supervisory oversight
  • Perform preventive and as-needed maintenance of analytical instrumentation
  • Author new documents such as testing methods, protocols, summary reports
  • Bachelor's or Master's degree with 3+ years of experience in an analytical laboratory environment
  • HPLC experience required; cGMP and/or ISO 9001 experience a plus
  • OpenLab and/or Empower experience a plus
  • Demonstrated ability to follow documented standard operating procedures
  • Must be able to multi-task and plan efficiently in a coordinated technical environment
  • Must possess strong verbal and written communication skills
  • Must be able to work effectively independently and as part of a team
  • Hands-on experience with LIMS/LES/CDS systems strongly preferred

CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: www.isotope.com

About Us:

Cambridge Isotope Laboratories, Inc. (CIL) is the world’s leading producer of stable isotopes and stable isotope-labeled compounds. With approximately 750 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CIL’s products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.

We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.

After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.

 

Learn more about us on our website: www.isotope.com

Average salary estimate

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What You Should Know About Quality Control Analyst II, HPLC, Cambridge Isotope Laboratories, Inc.

Cambridge Isotope Laboratories, Inc. (CIL) is on the lookout for a passionate Quality Control Analyst II to join our dynamic Research Products/ISO department! If you're excited about high-tech scientific advancements and love working in a collaborative environment, this is the job for you. Based out of our Andover, MA facility, you will perform essential analytical techniques primarily through HPLC to assess isotopic enrichment, chemical purity, and identity testing on a diverse range of stable isotope-labeled materials. Picture yourself at the forefront of groundbreaking collaborations across academia and the pharmaceutical sector. You’ll work closely with our production chemists and the Supply Chain group to ensure the highest quality standards in our ISO 17034 reference materials program. We're looking for someone with at least 3 years of experience in an analytical laboratory setting and solid HPLC expertise. Communication is key, as you'll be drafting testing methods, protocols, and summary reports while keeping everything aligned with established operating procedures. Whether you’re troubleshooting with supervisory guidance or maintaining sophisticated analytical instruments, your contributions will be integral to our mission. Plus, with generous benefits—including 6% matching on 401K and health insurance with no in-network deductible—your well-being is a priority! Join CIL, where your work aids in the creation of stable isotopes that push the boundaries of medical and scientific research. Discover a fulfilling career with long-term growth potential amongst dedicated professionals who have been part of the CIL family for many years.

Frequently Asked Questions (FAQs) for Quality Control Analyst II, HPLC Role at Cambridge Isotope Laboratories, Inc.
What responsibilities does a Quality Control Analyst II have at Cambridge Isotope Laboratories, Inc.?

A Quality Control Analyst II at Cambridge Isotope Laboratories, Inc. holds a pivotal role in ensuring the quality and consistency of stable isotope-labeled materials. They focus on conducting routine analyses mainly using HPLC techniques while also engaging in troubleshooting and preventive maintenance of analytical instruments. This position includes drafting and documenting testing methods and collaborating closely with production chemists and the supply chain group to meet ISO 17034 standards.

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What qualifications are required for a Quality Control Analyst II at CIL?

To qualify for the Quality Control Analyst II position at Cambridge Isotope Laboratories, Inc., candidates should possess either a Bachelor's or Master's degree paired with at least 3 years of experience in an analytical laboratory environment. Essential qualifications include extensive knowledge of HPLC and ideally familiarity with cGMP and ISO 9001 standards. Proficiency in OpenLab and Empower software, as well as experience using LIMS/LES/CDS systems, are highly beneficial.

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What is the work environment like for a Quality Control Analyst II at CIL?

At Cambridge Isotope Laboratories, Inc., the work environment for a Quality Control Analyst II is collaborative and supportive. Employees work in a small company atmosphere that fosters team camaraderie and values individual contributions. With a history of long tenures among senior managers, CIL emphasizes employee growth, well-being, and job satisfaction, making it a perfect place for quality-focused professionals to thrive.

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What benefits does CIL offer to Quality Control Analyst II employees?

CIL offers a comprehensive benefits package to its Quality Control Analyst II employees, which includes generous paid time off, a 6% matching 401K plan, and health insurance with no in-network deductible. Additionally, the company supports a healthy work-life balance, allowing employees to focus on both their career growth and personal well-being.

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What role does HPLC play in the responsibilities of a Quality Control Analyst II at Cambridge Isotope Laboratories, Inc.?

HPLC plays a crucial role in the responsibilities of a Quality Control Analyst II at Cambridge Isotope Laboratories, Inc. It is the primary analytical technique utilized for conducting routine analyses on stable isotope-labeled materials. Mastery of HPLC allows the analyst to effectively determine isotopic enrichment, chemical purity, concentration, and identity testing, ensuring the highest quality standards for CIL's diverse products.

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Common Interview Questions for Quality Control Analyst II, HPLC
Can you describe your experience with HPLC and how it relates to the Quality Control Analyst II role?

Discuss your direct experience with HPLC, focusing on specific projects where you've utilized this technology in an analytical setting. Highlight particular methodologies you've employed, challenges you’ve overcome, and any relevant outcomes to showcase your expertise.

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How do you ensure compliance with standard operating procedures in your analytical processes?

Explain your approach to adhering to standard operating procedures. Discuss the importance of documentation and training you have undertaken to stay current with SOPs, as well as examples of how you've successfully implemented these practices in past roles.

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Describe a challenging troubleshooting issue you faced in an analytical lab and how you resolved it.

Share a specific situation where you encountered a troubleshooting challenge. Detail the steps you took to diagnose the issue, the problem-solving techniques you used, and the final resolution. This illustrates your analytical skills and resilience under pressure.

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What experience do you have with LIMS/LES/CDS systems?

Detail your familiarity with Laboratory Information Management Systems, Laboratory Execution Systems, and Chromatography Data Systems. Describe how you have used these technologies to manage data, enhance workflow efficiency, or improve lab operations in your previous roles.

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How do you prioritize multiple tasks in a technical environment?

Discuss techniques you use for prioritization, such as creating task lists, assessing deadlines, and communicating with team members. Provide an example of a situation where you effectively balanced multiple responsibilities to meet project goals.

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What achievements have you made in quality control that demonstrate your capabilities?

Highlight concrete achievements related to quality control such as improvement metrics, successful project completions, or recognitions you've received. Be sure to connect these achievements back to quality enhancement and the impact on your team or organization.

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How do you keep up with new regulatory requirements in the quality control field?

Explain your proactive approach to staying informed, whether it’s through attending workshops, following industry news, or participating in professional organizations. Discuss instances where you have applied new regulations in your work effectively.

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What makes you a suitable candidate for the Quality Control Analyst II position at CIL?

Identify key skills and experiences that align with the requirements of the role. Tie your background, technical skills, and enthusiasm for the industry to what CIL values. Demonstrating a clear understanding of the company’s mission and how you fit is essential.

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How do you communicate complex analytical findings to team members who may not have a technical background?

Discuss your approach to simplifying complex data, using visual aids, and fostering open discussions to ensure understanding. Share an example where you successfully communicated findings to non-technical stakeholders, emphasizing clarity and engagement.

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What role do you see stable isotopes playing in future research developments?

Share your insights on the potential applications of stable isotopes. Discuss advancements in related fields like pharmaceuticals, environmental science, or biotechnology, and how you believe these developments could shape future research endeavors.

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