- Research Associate
Responsible for performing research and development experiments for projects and products,
in collaboration with others. Regularly exercises technical discretion in the design,
execution and interpretation of experiments that contribute to project goals. Contributes
to project process within scientific discipline through innovative research. Prepares
technical reports, summaries, protocols and quantitative analyses.
- Research Assistant
Responsible for performing research and development experiments for projects and products,
in collaboration with others. Projects may require the exercise of technical discretion
in the design, execution or interpretation of experiments. Makes detailed observations,
analyzes data and interprets results. Prepares technical reports, summaries, protocols
and quantitative analyses.
- Clinical Research Associate
Key participant in the design, implementation and monitoring of clinical trials, preparation
of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic
reports, PLAs, etc. Participates in design and writing of protocols, case report forms
and informed consent forms for clinical trials. Productive in recruitment/selection
of new investigators, contract research organizations and outside vendors. Responsible
for planning and implementing all activities required to conduct and monitor complex
clinical trials and ensure that Good Manufacturing Practices (GMP) are followed.
Conducts site visits pre-study, at study initiation, at regular intervals during the
study and at closeout. Monitors investigator performance and adherence to protocol.
- Clinical Data Associate
Primary responsibility is to ensure the validity of clinical trials and format them
for statistical purposes. Also designs collection instruments, sets up databases
and tracks and manages the flow of data to and from the investigative sites. With
supervision, establishes protocol-specific data review and entry guidelines to document
the validation and formatting procedures and defines batch-ending programs. Monitors
timely data entry. Review data discrepancies resolutions provided by the investigative
sites and enter corrections into the database, as appropriate. Assists in the review
of interim/final data listings prior to transmission to other groups or inclusion
in interim/final reports.
- Clinical Database Programmer Analyst
Works as part of a project team or possibly as a team manager, to design and implement
applications in support of Clinical Research and Biostatistics. Leads the analysis,
design and implementation of client-server applications such as Oracle, SQL and forms
of GUI-based products. Develops forms, menus and reports based on functional and
design specifications. Documents all work fully according to Clinical Information
Systems (CIS) standards. Actively promotes standards for the development and acquisition
of systems. Participates in the evaluation and implementation of packaged systems.
- Database Specialists
Provides for the storage and retrieval of research data for decision-making, intellectual
property submissions, regulatory petitions, and due-diligence purposes. In addition,
the positions may monitor current publications, research and available references.
- Scientific Writer
Responsible for the timely preparation, production and quality control of regulatory
documents, including coordinating with regulatory project teams, creating editorial
timelines and work flow specifications, scheduling and tracking documents, assessing
documentation staffing needs, participating in "round table" review of documents,
establishing project specific style guidelines, editing at various levels, writing
and proofreading. Develops and updates specifications for the design, format production
elements, tracking of regulatory documents and artwork used in regulatory documents.
- Documentation Assistant
Responsible for coordination and administration of document production procedures,
including planning and scheduling of work processing and production resources. Coordinates
with project teams in the development of timelines for regulatory submissions. Manages
electronic files. Coordinates with Scientific Editor to develop and update specifications
and procedures for design and format of documents and artwork policy and procedures.
Oversees reference collection, archive system, and produces monthly and annual reports
of regulatory submissions.
- Government and Regulatory Affairs Specialists
Provides support for regulatory submissions to FDA, EPA, USDA, and state/local regulatory
authorities. The position requires an understanding and conversant ability in the
area of technology and life sciences that the companies represent.
- Quality Control Analyst
Conducts routine and non-routine analysis of raw materials, in-process and finished
formulations under supervision and according to Standard Operating Procedures (SOPs).
Compiles data for documentation of test procedures and prepares reports. Calibrates
and maintains lab equipment. Reviews data obtained for compliance to specifications
and reports abnormalities. Revises and updates SOPs. May perform special projects
on analytical instrument problem solving.
- Quality Control Inspector
Performs a wide variety of inspections, checks, tests and sampling procedures for
the manufacturing process. Performs in-process inspection and documents results.
Monitors critical equipment and instrumentation. Writes and updates inspection procedures
and checklists as necessary.
- Microbiology Quality Control Supervisor
Designs, implements and validates microbiological testing protocols and recommends
appropriate specifications for raw materials, key reagents, bulk and finished products.
Establishes SOPs and key documentation systems for microbiological/environmental testing.
Implements validation studies for sterilization and autoclave cycles. Establishes
environmental monitoring to support GMPs.
- Quality Control Microbiologist
Performs routine microbiological testing of raw materials, in-process samples and
finished formulations according to Standard Operating Procedures (SOPs). Conducts
routine environmental monitoring of GMPs, manufacturing areas, equipment and processes
according to established procedures. Calibrates and maintains microbiology laboratory
equipment. Compiles and analyzes data for documentation of test results and prepares
related reports.
- Quality Assurance Documentation Specialist
Provides required documentation and implements documentation systems. Coordinates
the review and revision of procedures, specification and forms. Assists in compiling
regulatory filing documents and maintains computerized files to support all documentation
systems.
- Quality Assurance Technical Writer
Responsible for writing and editing SOPs, laboratory procedures manuals and regulated
documents. Integrates various sources of information into a uniform style and language
for regulatory compliance. Assists in documentation for instructional, descriptive,
reference and/or informational purposes.
- Validation Supervisor
Responsible for design and scale-up of processes, instruments and equipment from the
laboratory through pilot plant and manufacturing. Participates in the design and
start-up of new manufacturing facilities and equipment. Develops and recommends new
process formulas and technologies to achieve cost effectiveness and product quality.
Interfaces with various departments to ensure processes and designs are compatible
for new product technology transfers and to establish future processes and equipment
automation technology.
- Product Technical Supervisor
Coordinates the activity and technical positioning of product candidates or products.
The job includes technical writing and assistance with marketing messages from a technology
and regulated point of view. Critical position involved in the flow of many products
through the development process.
- Market Research Analyst
Responsible for researching and analyzing the company's markets, competition and
product mix. Performs literature research, analyzes and summarizes data and makes
representations on new market and technical areas. Analyzes the competitive environment,
as well as future marketing trends, and makes appropriate recommendations. Conducts
market surveys, summarizes results and assists in the preparation, presentation and
follow-up of research proposals.
- Marketing Coordinator
Assists in creating product initiatives and coordinates activity across disciplines
for a commercial product. Assists in the development of sales messages, features/advantages/benefits,
advertising and distribution support.
- Sales Representative
Responsible for direct sales of company products or services. Calls on prospective
customers, provides product information and/or demonstrations and quotes appropriate
customer prices. Also responsible for new account development and growth of existing
accounts within an established geographic territory. Must meet assigned sales quotas
and may handle key company accounts.
- Customer Service Representative
Responsible for ensuring product delivery in accordance with customer requirements
and manufacturing capabilities and responding to customer inquiries and satisfaction
issues. Answers telephones, takes product orders and inputs sales order data into
data systems. Investigates problems related to the shipment of products, credits
and new orders. May be responsible for sale order administration and/or inside sales.
- Technical Services Representative
Provides technical direction and support to customers on operation and maintenance
of company products. Serves as a contact for customers on technical and service-related
problems. Demonstrates uses and advantages of products.
myCSUSM
