Under minimal supervision, examines and analyzes company, vendor, or customer created
Instrumentation and Calibration documentation for compliance with global scientific and
regulatory standards such as Food and Drug Administration (FDA) standards. Will perform audits of instrumentation and calibration service documents and files created by both JCI staff and external vendors. Designated as the Compliance representative for the customer with the authority to validate that all instrument service documentation meets FDA Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) standards as well as customer Standard Operating Procedures (SOP). Involves desktop audits and on –site critical vendor audits.
1. Reviews service documentation produced by company Instrumentation and Calibration service
personnel on a daily basis to verify header information, data accuracy and that the applicable
SOP's were followed.
2. Conducts regular reviews and updates of customer's SOP's and other policies and procedures that relate to the Instrumentation and Calibration department.
3. Completes periodic audits of the customer's existing Instrumentation and Calibration files (such as training and instrument files), databases, and processes to assure compliance with FDA GMP/GLP standards.
4. Recommends and implements process and workflow improvements for both company and the
customer as it relates to the Instrumentation and Calibration service documents, databases
5. Prepares, assists, and participates in self audits, internal customer and external regulatory
6. Prepares, and participates in external Vendor approval assessments and audits. Assists with follow-ups regarding identified vendor approval assessment issues.
7. Assists company Instrumentation and Calibration service personnel in maintaining a high level of quality and consistency in the data and documentation produced, by providing regular
guidance on Quality issues, SOP'S, and good documentation practices.
8. Develops and implements new procedures governing company Instrumentation and Calibration service activities.
9. Helps d evelop and provide database generated compliance and performance reports for monthly metrics or as requested by the customer.
10. Complies with all company policies and procedures and adheres to company
11. Attends Quality Forum monthly meetings as needed to provide in-depth explanations for monthly training reports and metrics.
No formal supervisory responsibilities in this position. May provide informal assistance such as technical guidance and/or training to coworkers. May coordinate work and assign tasks.
At CBRE, you are empowered to take your career path into your own hands. Enjoy workplace flexibility in a global organization with tremendous scale. Work in an inclusive and collaborative environment with supportive teammates. Come experience the employee advantage at CBRE.
CBRE has a long-standing commitment to providing equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, pregnancy, age, citizenship, marital status, disability, veteran status, political belief, or any other basis protected by applicable law.
As a Fortune 500 worldwide leader in real estate services, CBRE's more than 70,000 professionals provide exceptional outcomes for clients in 60+ countries. When it comes to real estate, CBRE sees potential everywhere. We turn scale into strength, expense into performance, and property into prosperity. Visit CBRE.com .
With access to top-tier market intelligence, planning, local site selection and asset strategies, our Global Workplace Services offering includes Enterprise Facilities Management (EFM), Project Management (PJM), Advisory & Transaction Services (A&T), and Management Consulting. We offer end-to-end expertise across all workplace types, scalable delivery, a commitment to world-class safety and ongoing innovations in building efficiencies, energy conservation and CRE technology.
1. Bachelors Degree in basic or applied science (preferably with a pharmaceutical and health care emphasis), mathematics, or statistics or equivalent related work experience. Engineering background is preferred.
2. The position requires a minimum of three years in a FDA regulated environment such as the pharmaceutical, medical device, or food industry.
3. Specialized training or certification in quality assurance audits, preferably FDA or IS0-related is also required if conducting vendor audits.
4. Ability to identify Compliance Risks within responsible area.
5. Candidate must have experience in review or audit of regulated documentation
6. Experience with Microsoft Word and Excel, Access, or Crystal Reports skills required.
7. Word and Excel, Access, Documentum, or Crystal Reports skills required.
8. Demonstrated knowledge of basic electricity, physics, and chemistry is desired.
Internal Number: 18031236
With broader and deeper capabilities than any other company, CBRE is the leading full-service real estate services and investment organization in the world.
CBRE Group, Inc. is the world’s largest commercial real estate services and investment firm, with 2017 revenues of $14.2 billion and more than 80,000 employees (excluding affiliate offices). CBRE has been included in the Fortune 500 since 2008, ranking #214 in 2017. It also has been voted the industry’s top brand by the Lipsey Company for 17 consecutive years, and has been named one of Fortune’s “Most Admired Companies” in the real estate sector for six years in a row. Its shares trade on the New York Stock Exchange under the symbol “CBRE.”
CBRE offers a broad range of integrated services, including facilities, transaction and project management; property management; investment management; appraisal and valuation; property leasing; strategic consulting; property sales; mortgage services and development services.