Cgmp Quality Assurance Specialist

Cambridge Isotope Laboratories, Inc. Xenia , OH 45385

Posted 6 days ago

Cambridge Isotope Separations (CIS) has an outstanding opportunity for an experienced cGMP Quality Assurance Specialist based onsite in our Xenia, OH location. CIS is the world leader in the separation of stable isotopes and related chemistry. CIS and its parent, Cambridge Isotope Laboratories (CIL) in Massachusetts, are subsidiaries of the Otsuka Pharmaceutical Group. CIL separates both 13C and 18O at its Xenia, Ohio, facility and operates the only large capacity nongovernmental Deuterium Oxide enrichment columns in the world. We globally support a broad range of customers across many high-tech industries including pharmaceutical, semiconductor, medical diagnostic, display and basic research. We are rapidly expanding, and the Ohio facility is an integral part of our growth for the future.

Under minimal supervision, utilizing in-depth knowledge and understanding of cGMP (current Good Manufacturing Practices), QA (Quality Assurance) and the companys production capabilities, the incumbent is responsible for the implementation, maintenance, and continuous improvement of CIS' Quality Management Systems.

  • Responsible for batch record review.
  • Responsible for release of raw materials and finished products.
  • Primary coordinator of the CIS CAPA (Corrective Action and Preventative Action) program. This includes reviews of sufficient root cause analysis, review/approve CAPA and effectiveness plans, perform effectiveness check, etc.).
  • Assist and/or perform internal audits.
  • Assist with external audits, including supplier audits.
  • Perform related QA functions in support of ISO and the cGMP QMSs to include but not limited to: batch release and data review, document writing/revision, closing deviations, investigating OOS (Out of Specification) results, room clearances, non-conformance and training.
  • Perform equipment qualification protocol reviews and approvals.
  • Author annual product reviews (APRs) for APIs and related products.
  • Perform any related work as required.


  • Bachelors Degree in chemistry or related field of study preferred; equivalent applicable industry experience may be substituted for the degree requirement.
  • Minimum 4-7 years of experience in a GMP setting.
  • Knowledge and/or experience with ISO 9001, 21 CFR 212 and/or ICH Q7 is preferred.
  • Excellent interpersonal, verbal and written communication skills are required.
  • Attention to detail, organizational skills, ability to multitask and follow tasks through to completion. Work independently and in a team environment.
  • Work is performed primarily in an administrative office environment; however, some work is performed in an industrial plant environment.


CIS offers a competitive salary and a comprehensive benefit program including generous paid time off, health insurance with no in-network deductibles, Long Term Incentives and 6% matching 401K plan.

CIS is an EEO/Affirmative Action employer.

Learn more about us on our website:

About us:

Cambridge Isotope Laboratories, Inc. (CIL) is the worlds leading producer of stable isotopes and stable isotope-labeled compounds. With nearly 600 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). CILs 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:

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Makerspace Specialist 20 Hrs/Week

Greene County Public Library

Posted 2 weeks ago

VIEW JOBS 9/6/2022 12:00:00 AM 2022-12-05T00:00 <p><strong>Job Title:</strong> Makerspace Specialist</p><p><strong>Classification:</strong> Specialist</p><p><strong>Starting Rate:</strong> $19.00 per hour <strong>Pay <b>Grade: </b></strong>19</p><p><strong>Location / Department:<br></strong> Xenia Community Library / Spark Place</p><p><strong>Reports to:</strong> Innovation & Makerspace Manager</p><p><strong>Employment Status:</strong> Part Time</p><p><strong>FLSA Status:</strong> Non-Exempt | Bargaining Unit</p><p><strong>Hours:</strong> Part time, 20 hours per week (schedule includes daytime, evening and weekend hours)</p><h3>Job Objective<br></h3><p>To promote the mission and values of the Greene County Public Library. To carry out objectives and goals of the strategic plan to better serve the community. To perform a variety of makerspace tasks while maintaining a high level of customer service. To work under direct supervision but at times may work unsupervised and may be expected to solve problems and serve patrons independently.</p><p><strong>Requirements</strong></p><h3>Essential Job Functions<br></h3><ul><li>Instructs and aids library users in use of makerspace equipment and associated software; provides both one-to-one assistance and group instruction.</li><li>Plans, designs, promotes, presents, and evaluates makerspace programs for patrons of all ages.</li><li>Plans and/or prepares displays, pathfinders, or other informational materials.</li><li>Troubleshoots all equipment in the makerspace, performing simple repairs as applicable.</li><li>Gathers statistics, prepares reports, and completes other projects as assigned.</li></ul><ul><li>Attends conferences, workshops, seminars, and training to maintain knowledge as reflected in training curriculum. </li></ul><ul><li>Keeps abreast of information by regularly reading email, minutes and staff website as well as attending staff meetings. </li></ul><ul><li>Performs tasks of lower level classifications as necessary. </li></ul><ul><li>The supervisor may require other related duties. These duties are nonessential functions of this position. </li></ul><h3>Skills, Knowledge and Abilities<br></h3><ul><li>Ability to provide knowledgeable customer service to assist all library patrons in a timely manner; show tact and courtesy in relations with the public and other staff members.</li></ul><ul><li>Ability to communicate clearly and read printed and on-screen information.</li><li>Demonstrated knowledge of working with specialized equipment. </li><li>Ability to multi-task, work in a fast paced environment and handle difficult situations.</li><li>Some knowledge of 3D modeling and printing/fabrication.</li><li>Some knowledge of computer programming such as Scratch, Arduino, or more.</li><li>Working knowledge and experience in DIY and making.</li><li>Experience with robotics and electronics including, but not limited to, Legos, Arduinos, Raspberry Pi, Little Bits, etc.</li><li>Experience with electronics soldering and the use of power tools.</li><li>Ability to handle routine problems under guidance of supervisor and keep supervisor informed of departmental needs and concerns.</li></ul><h3>Qualifications</h3><ul><li>Bachelor’s degree from an accredited college or university required or any equivalent combination of experience and training required.</li></ul><ul><li>1-3 years of Customer Service experience strongly preferred.</li></ul><h3>Environmental Conditions</h3><ul><li>Work is performed in a makerspace setting, with need for considerable mobility: light lifting, bending, stooping, stretching, standing, and sitting at a variety of work benches and desks.</li><li>Employee may be scheduled to work evening and weekend hours, including Sundays; schedules may be altered depending on the needs of the library.</li></ul><p><strong>Benefits</strong></p><ul><li>The library pays an amount equal to 14% of each employee’s salary into the <a href="" rel="nofollow noreferrer noopener" class="external">Ohio Public Employee Retirement System</a>, the employee pays 10% to OPERS</li><li>The library contributes a percentage of the employee’s salary for Medicare</li></ul><ul><li>Vacation (10 days per year)</li><li>Sick leave (12 days credit per year)</li><li>Personal leave (3 days credit per year)</li><li>Holidays, including birthday (10 days possible per year, depending on scheduling)</li><li>Merit time off, if warranted</li><li>Bereavement time, if needed</li><li>Employee Assistance Program for employee and eligible family members</li><li>Voluntary participation in the <a href="" rel="nofollow noreferrer noopener" class="external">Ohio Deferred Compensation</a> Plan</li><li>Eligibility for Tuition Reimbursement program after one full year of employment (between $2000 and $2800 per year depending on the subject being studied)</li></ul><ul><li>Dental insurance: employer pays for a single premium amount based on the amount of budgeted hours; additional coverage for dependents is at employee expense</li></ul> Greene County Public Library Xenia OH

Cgmp Quality Assurance Specialist

Cambridge Isotope Laboratories, Inc.