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Career Based Positions include:
Current Job Openings
CimQuest, Inc., a premier provider of consulting,
validation and technology implementation services to
the pharmaceutical and biotechnology industry, is
experiencing rapid growth as our quality reputation
gains recognition. Career opportunities at all
levels are available with excellent benefits and
compensation, including 401(k). We offer a dynamic
work environment, a comprehensive training program
and ongoing opportunities for growth and
development.
For consideration please
send resume to any of the following:
E-mail:
john.evans@cimquest.com
Fax: 610-363-0428, ATTN: Director of Recruiting
Mail: CimQuest, Inc., Director of Recruiting
35 E. Uwchlan Ave., Suite 330, Exton, PA 19341
Subject Matter Experts
The Subject Matter Expert (SME) provides
technical and business guidance to senior management
and Sales & Marketing and actively participates in
new business development activities including
strategic business planning, marketing/sales
planning, sales presentations, proposals and
closures. SMEs are established for each of
CimQuest's core business competencies and include
core technology areas of; Automation and Control
Systems, Laboratory and Laboratory Information
Management Systems, Clinical and Quality Systems,
Computer Systems Validation and Information
Technology/Global Business Systems. Extensive
knowledge in a wide variety of technical (including
applied computer systems validation methodology in
the GMP, GLP, GCP or 510(k) environment), business
(Business Planning, Marketing/Sales experience for
complex computerized systems), and marketing
(demonstrated successful project management
experience, including scheduling, manpower loading,
budgeting and project controls) applications are
required.
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Senior Compliance
Consultants
Senior Compliance Consultant with 7-15 years
experience to assume a leadership role in our work
in the FDA regulated industries. A BS or MS in a
scientific discipline is required, as well as
knowledge of GMP, 510(k), GCP and GLP regulations.
Must be experienced with compliance and validation
of automated processes and be able to manage a
project. Knowledge of PLC Technologies, QA, LIMS,
MES, MRP and data acquisition software knowledge
preferred. Site travel required.
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Senior Compliance
Engineers/Specialists
Senior Compliance Engineers/Specialists provide
process, product and software validation, equipment
and facility qualification. The position requires
good written and oral communication skills, computer
literacy, as well as knowledge of GMP, 510(k), GCP
and GLP regulations. A technical degree or
equivalent is necessary. Experience with validation
of automated processes and Clinical Trial Data
Management a plus. Knowledge of PLC Technologies,
DCS, MES, MRP and LIMS preferred. Travel and site
work required. Varied assignments. Candidates must
have a minimum of three (3) years of practical work
experience in the pharmaceutical or other FDA
regulated field involving participation in
Validation Test Development and execution projects.
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Compliance
Engineers/Specialists
Openings exist at all levels for specialists who
can provide process, product and software
validation, equipment and facility qualification.
Position requires good written and oral
communication skills, computer literacy, as well as
knowledge of GMP, 510(k), GCP and GLP regulations.
Technical degree or equivalent is necessary.
Experience with validation of automated processes
and Clinical Trial Data Management a plus. Knowledge
of PLC Technologies, DCS, MES, MRP and LIMS
preferred. Travel and site work required. Varied
assignments.
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Compliance Assistants
Responsible for assisting in the development and
execution of Validation Test Plans, IQ/OQ protocols
and modifying or generating supporting SOPs and
Quality Project Plans. Job knowledge requirements
include; familiarity with validation test plans and
their associated execution, proficiency in the use
of Microsoft office computer software, knowledge of
Quality Assurance principals and their application
to engineering, procurement or software development
and systems validation, and knowledge of GMP, GLP or
510 (k) Regulations. Candidates must be proficient
in oral and written communications, and have an
awareness of Systems Development Life Cycle (SDLC)
and software testing methodology and techniques.
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Project Assistants
Responsible for providing administrative support
to Systems Regulatory Compliance Group activities at
home office and client locations. Candidates must
possess excellent skills in the use of Microsoft
Office computer software including but not limited
to Word, Excel and Project, have an awareness of GMP,
GLP, or 510 (k) Regulations, and must possess
excellent oral and written communication skills. A
High School degree or equivalent is required along
with specialized courses in computer science, word
processing, writing or a specialized discipline. A
minimum of 1 year of practical work experience in
the fields of word processing, technical writing or
office administration is required.
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Technical Writers
Technical Writers are responsible for developing
and compiling all Validation Test Plans, IQ/OQ
Protocols, and modifying or generating SOPs and
Quality Project Plans. Candidates must have a solid
technical knowledge and understanding of validation
test plans, IQ/OQ documents, SOPs and Quality
Project Plans, must have proficiency in the use of
Microsoft Office computer software including Word,
Excel and Project, and a working knowledge of GMP,
GLP, GCP or 510 (k) Regulations. Excellent oral and
written communication skills are required. This
position requires an Associate Degree in a
scientific, engineering or computer related
discipline along with specialized courses in
engineering, quality or a specific discipline. A
minimum of 1 year of practical work experience in
the fields of engineering, procurement,
pharmaceutical validation, technical writing or
business administration is required.
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Quality Systems
Specialists
Responsible for performing internal audits and
surveillances, supplier audits, and for providing
consultative assistance to clients to evaluate QA
program compliance to established standards and
assess the adequacy and effectiveness of their total
quality program. Must have audit experience, strong
understanding of SDLC methodologies and knowledge of
FDA, GMP, GCP, GLP or 510(k) regulations. Knowledge
of GAMP and 21CFR 11 preferred. CQA and SQE
certification desired. Certification to PDA
Technical Report 32 required.
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IT & MES Professionals
Immediate job openings for Information Technology
and Manufacturing Execution System Professionals
with practical experience in Enterprise and Plant
Information Management Systems (ERP, MRPII,
Inventory Management and Tracking, Scheduling).
Positions require demonstrated experience in
interfacing with clients for development of planning
and requirements documents, as well as
implementation of database-centric applications
(Oracle and SQL Server) in client server
environments. APICS CPIM and/or CIRM a plus.
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Network
Consultants
A Network Consultant should have a strong
background in networking technologies and concepts
including TCP/IP, VPN, firewalls, and
virus/intrusion detection. The position requires
knowledge of both logical and physical network
configuration, router/routing, layer switching,
hubs, gateways etc. A complete knowledge of security
as it relates to computer systems is required.
Experience with backup/restore and disaster recovery
is also required. Strong writing and communication
skills are a must. Knowledge of GxP's is a plus.
Relevant Cisco, Microsoft, ISC2 certifications a
strong plus. Site travel required.
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Part
11 White Paper
