GBI-294: Regulatory Affairs Manager
The selected candidate will establish group priorities and insures that timelines are met. Prepares or coordinates Regulatory filings in the US and other countries. Acts as a liaison between other departments regarding current FDA regulations and operating procedures. Researches and determines applicability of changes in FDA regulations. Submits to FDA all required licenses and reports as needed.

You will perform regulatory review of company product performance characteristics and determine regulatory strategy for new products. Prepares FDA 510(k), Japanese and European submissions. Acts as liaison between other departments regarding current FDA regulations and operating procedures. Provides information to external customers and other miscellaneous activities. Implements changes in labeling as per FDA, Marketing, or other department request. Reviews customer complaints for compliance and assesses whether corrective and preventative action is required. Reviews and approves PCOs for Regulatory Assessment. Reviews CE Mark and "add-to-file" technical files for completeness and accuracy prior to FDA submission. This position has the authority to submit Regulatory documentation to the FDA, and serve as the primary company contact for FDA submissions. Acts independently to determine methods and procedures on new assignments.

Qualifications include a minimum BA/BS degree in a scientific related field with a minimum of 3-5 years related experience within the IVD "In Vitro Diagnostics" industry and/or training or equivalent combination of education and experience. You must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Ability to follow and give clear written and verbal directions with a high level of accuracy. Skilled at analyzing data and summarizing results. This position may supervise junior employee's. Apply Now TOP MENU

GBI-290: Quality Engineer
The selected candidate will be responsible for evaluation of company Quality Systems, including processes involving site compliance for ISO 13485, CMDR and FDA Quality System requirements. Position helps assure the appropriate Quality Systems are effectively implemented to comply with regulations. You will develop and prioritize an auditing schedule and perform internal quality audits in support of ISO, CMDR and FDA Quality System regulations. Exercise good judgment within defined procedures and practices to evaluate appropriate corrective and preventive actions. Expedite closure of internal and external audit observations. Assess closure of audit observations for timeliness, completeness of root cause, corrective action and preventive action. Prepare and distribute Quality Reports which include graphical analysis of auditing activities. Facilitate educational training sessions to communicate key Quality System information, including ISO, CMDR, and FDA Quality System training. Perform supplier quality audits in support of ISO, CMDR, and FDA Quality System requirements. This position has the authority to request additional documentation or further clarification from Process Owners to complete responses to audit observations. Participate in external audit activities as directed.

Qualifications include a BA/BS degree or equivalent in a related field. The ideal candidate will have 5-7 years with ISO, CMDR and FDA Quality System Regulation in an IVD/Medical Device environment. Expertise with CAPA, SCAR, Complaint handling and NCAR is required. You should have knowledge and experience of the regulatory requirements pertaining to cGMP and ISO 13485. Able to use Microsoft Office tools (Word, Excel, Access). Strong organizational skills, detail oriented, ability to meet deadlines and handle multiple projects. Excellent written and oral presentation skills. Must exhibit professionalism, be pro-active, an advocate for change and self motivated. We may also consider candidates at the Supervisor or Manager level. Apply Now TOP MENU

GBI-289: Technical Support Representative
The selected candidate will provide customers and end users with product and technical support. You will respond to customer inquiries on the telephone, through on-line networks or by mail or fax. Willingness to return customer calls after office hours rotating with other Tech Support Reps. Communicates with customers to help them understand how to use the product properly. Handles customer problems that appear to arise from the use of the product. Handles requests for replacing defective products. Completes, maintains and processes pertinent paperwork and records. Provides periodic reports to management including product compilations, suggestions and trend analyses. Maintains a current source of reference material, articles, and technical manuals as required to provide current information. Reviews available technical literature to maintain an awareness of current methods and systems. Performs services for departments, customers and OEM partners. Makes recommendations to, negotiates with and influences actions of other departments, customers and OEM partners.

Qualifications include a BA/BS degree in Chemistry, Medical Technology or Immunology with 2-4 years related experience or equivalent combination of education and experience. Excellent written and verbal communication skills are required. Working knowledge of Windows based spreadsheets, word processors and database management software. Familiarity with scientific and clinical laboratory terminology and testing. Ability to understand basic chemistry and chemical reactions.
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GBI-277: Quality Systems Associate
The selected candidate will with Regulatory Affairs to audit batch records and associated documents to ensure that all documentation and specification requirements are met. You will identify non-conformances and errors found during the batch record review process and trend batch record issues. This will encompass the batch record review of raw materials, in-process and finished goods materials and processes. Review batch record supporting documentation, worksheets, temperature logs/charts, equipment logs, equipment print outs, non-conformity reports, CAPA etc. to ensure documentation is completed accurately and completely. You will track, trend and review statistics and corrective actions resulting from batch record issues.

Qualifications include a high school diploma or equivalent with 2-4 years of industry experience. You should have competent knowledge of GMP/QSR/GDP regulations. Previous experience working with batch records is a plus. You must be proficient in MS Word, Excel and PowerPoint. You should be detail oriented, have excellent oral and written communication skills and exhibit the ability to find and solve problems.Apply Now TOP MENU

GBI-210: Clinical Laboratory Supervisor
The selected candidate will oversee the operation of the clinical pathology laboratory. Schedule workload with clients. Assure GLP and SOP compliance with all aspects of the operation from sample receiving to completion of the evaluation report and filing of the raw data packet. On a daily basis, evaluate analytical data generated in the laboratory and upon completion of the study, prepare an evaluation report for each study if necessary. Keep management and study directors informed on progress of studies. Promptly notify management and study directors of any technical problems or unusual findings, which may affect the integrity and validity of the study. Keep current on laboratory procedures and practices to assure that methods and instruments employed are suitable and up-to-date. Actively investigate new instrumentation, methodologies, and computer applications. Recommend purchase and/or inclusion in the annual budget proposals. Recommend hiring, promotion, or termination of staff. Work with staff to set individual goals and evaluate performance and achievements semi-annually and at periodic intervals. Prepare extensive semi-annual and annual report of laboratory activities and achievements. Perform analyses and maintain records according to written GLP and SOP requirements.

Qualifications include a BA/BS degree in the clinical laboratory sciences or closely related with 5-10 years experience in human, veterinary, and/or pharmaceutical clinical laboratory. You should have 1-5 years of supervisory/management responsibility in pharmaceutical or contract laboratory. A license or certification by national or state organization, which recognizes education and competency in medical technology, e.g., ASCP, NCA or State of California license. This is a mid shift position.
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