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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
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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.
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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
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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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