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Pharmaceutical, Clinical, and Laboratory Job Descriptions

Animal Handler

An animal handler is responsible for the daily care of research animals for experimental purposes. He or she cleans animal cages and racks, maintains records to comply with regulatory requirements and standard operating procedures, and performs preventive maintenance on facility equipment. The incumbent may also perform animal observation, grooming, and minor clinical tasks. An animal( See Definition )


Animal Technician

Animal technicians are responsible for the daily care of research animals for experimental purposes. They also coordinate with vendors and supervisors on operational, administrative, and technical responsibilities. They perform some surgery and postoperative care as directed and are responsible for overseeing procurement of animals and supplies, preventive maintenance of facility equipment, cleaning of animal cages( See Definition )


Assay Analyst

An assay analyst is responsible for doing cell cultures and performing assays and tests on tissue and cell cultures following standard protocols. He or she prepares glassware, reagents and media for cell culture use. He or she also performs, prepares and maintains tissues and cell cultures and maintains records required by good manufacturing procedures. An( See Definition )


Biochemical Development Engineer

A biochemical development engineer is responsible for the design and scale-up of processes, instruments, and equipment from the laboratory through the pilot plant and manufacturing process. He or she assists the manufacturing operations in problem solving with regards to equipment and systems and participates in the design and start-up of new manufacturing facilities and equipment.( See Definition )


Biostatistician

A biostatistician works with others to define and perform analyses of databases for publications, presentations to investigator meetings, and for meetings of professional societies. A position as a biostatistician requires at least a master’s degree in biostatistics and 1 to 4 years’ related experience.( See Definition )


Buyer

A buyer is responsible for obtaining materials, scientific equipment, and services. He or she checks requisitions, obtains price quotations, examines bids, and awards contracts. A buyer develops new supply sources where vendors and suppliers are inadequate. He or she coordinates purchasing activities with other departments to maintain inventory at planned levels. As required, a buyer( See Definition )


Clinical Coordinator

A clinical coordinator must be familiar with the scientific/investigative process. Expertise may be limited to a specific functional area. A clinical coordinator must have good communications skills, both written and oral. He or she must also have project team experience and a familiarity with standard computer applications. Responsibilities include coordinating the clinical development plan as( See Definition )


Clinical Data Specialist

A clinical data specialist is responsible for collaborating with various departments on the design, documentation, testing and, implementation of clinical data studies. He or she develops systems for organizing data to analyze, identify, and report trends. A clinical data specialist also analyzes the interrelationships data and defines logical aspects of data sets. A starting position( See Definition )


Clinical Programmer

A beginning clinical programmer is responsible for coordinating and monitoring the flow of clinical data into the computer database. He or she analyzes and evaluates clinical data, recognizes inconsistencies, and initiates the resolution of data problems. He or she implements data management plans designed to meet project and protocol deadlines, and consults in the design( See Definition )


Clinical Research Administrator

A clinical research administrator is responsible for clinical data entry and validation to ensure legibility, completeness, and consistency of data. He or she assists users with requests for clinical documents and is responsible for working with physicians and/or their staff to clarify any questionable information. He or she may be responsible for auditing internal patient( See Definition )


Clinical Research Associate

A clinical research associate is responsible for the design, planning, implementation, and overall direction of clinical research projects. He or she evaluates and analyzes clinical data and coordinates activities of associates to ensure compliance with protocol and overall clinical objectives. He or she may also travel to field sites to supervise and coordinate clinical studies.( See Definition )


Customer Service Representative

Customer service representatives are responsible for ensuring product delivery in accordance with customer requirements and manufacturing capabilities and for responding to customer product inquiries and satisfaction issues. He or she answers telephones, takes product orders, and inputs sales order data into consumer data systems. He or she also investigates problems related to the shipment of( See Definition )


Documentation Coordinator

A documentation coordinator provides clerical and administrative support related to a company’s documentation system requirements. He or she audits all documentation manuals to ensure that they are accurate and up-to-date and available to appropriate personnel. A documentation coordinator also files and retrieves all master documents. The position requires a high school diploma or equivalent and( See Definition )


Documentation Specialist

An entry-level documentation specialist is responsible for coordinating all activities related to providing required documentation and implementing related documentation systems. He or she coordinates the review and revision of procedures, specifications, and forms. He or she also assists in compiling regulatory filing documents and in maintaining computerized files to support all documentation systems. The job( See Definition )


Drug Experience Coordinator

The major responsibility of a drug experience coordinator is to handle the drug experience activities for marketed products. The candidate will also provide drug information on the products. He or she will oversee day-to-day processing of adverse event information for marketed products and ill coordinate the receipt, classification, investigation, and processing of adverse experience reports.( See Definition )


Environmental Health and Safety Specialist

An environmental health and safety specialist is responsible for developing, implementing, and monitoring industrial safety programs within the company. He or she inspects plant areas to ensure compliance with Occupational Safety and Health Administration (OSHA) regulations. He or she evaluates new equipment and raw materials for safety, and monitors employee exposure to chemicals and other( See Definition )


Glasswasher

A glasswasher is responsible for washing and drying glassware and distributing it to appropriate locations within the laboratories. He or she maintains the glass-washing facility, keeping it clean and swept, and picks up dirty glassware. He or she may sterilize glassware and other items using an autoclave. A glasswasher performs routine maintenance of glass-washing equipment( See Definition )


Greenhouse Assistant

A greenhouse assistant performs a variety of greenhouse research tasks and experiments. He or she may be required to make detailed observations, detecting horticultural or pest problems, and instituting corrective action. Greenhouse assistants determine optimal cultural requirements and perform tasks related to disease and pest prevention; they often are required to collect, record, and analyze( See Definition )


Human Resources Representative

A representative in human resources is responsible for a variety of activities in personnel administration, including employment, compensation and benefits, employee relations, equal employment opportunity, and training programs. He or she conducts job interviews, counsels employees, maintains records, and conducts research and analyzes data on assigned projects. An entry-level position as a human resources representative( See Definition )


Instrument / Calibration Technician

An entry-level instrument/calibration technician is responsible for performing maintenance, testing, troubleshooting, calibration, and repair on a variety of circuits, components, analytical equipment, and instrumentation. He or she also calibrates instrumentation, performs validation studies, and specifies and requests purchase of components. He or she analyzes results, may develop test specifications and electrical schematics, and maintains logs( See Definition )


Laboratory Assistant

Laboratory assistants are responsible for performing a wide variety of research laboratory tasks and experiments, making detailed observations, analyzing data, and interpreting results. He or she maintains laboratory equipment and inventory levels for laboratory supplies. He or she may also write reports, summaries, and protocols regarding experiments. A laboratory assistant also performs limited troubleshooting and( See Definition )


Library Assistant

A library assistant maintains serial control, and locates and orders journal articles and/or books that are unavailable at local libraries on relevant subjects. He or she performs special data-gathering projects as requested, and is responsible for on-line computer searching of scientific databases. The position of entry-level library assistant requires an associate degree or equivalent and( See Definition )


Manufacturing Engineer

A manufacturing engineer is responsible for developing, implementing, and maintaining methods, operation sequences, and processes in manufacturing. He or she works with the engineering department to coordinate the release of new products. He or she estimates manufacturing costs, determines time standards, and makes recommendations for process requirements of new or existing product lines. As required,( See Definition )


Manufacturing Research Associate

A manufacturing research associate is responsible for the implementation of production procedures to optimize manufacturing processes and regulatory requirements, and has responsibilities in packaging and distribution processes. He or she may also help maintain production equipment. The position requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0( See Definition )


Manufacturing Technician

Manufacturing technicians are responsible for the manufacture and packaging of potential and existing products. They operate and maintain small production equipment; weigh, measure, and check raw materials, and ensure that manufactured batches contain the proper ingredients and quantities. They maintain records and clean production areas to comply with regulatory requirements, good manufacturing practices, and standard( See Definition )


Market Research Analyst

A market research analyst is responsible for researching and analyzing the company’s markets, competition, and product mix. He or she performs literature research, analyzes and summarizes data, and makes presentations on new market and technical areas. He or she also analyzes the competitive environment, as well as future marketing trends, and makes appropriate recommendations. He( See Definition )


Media Prep Technician

A media prep technician is responsible for media preparation in the research and development area. He or she performs experiments as required and outlined, and develops and maintains record keeping for procedures and experiments performed. A media prep technician entry-level position requires at minimum an associate degree in science and 0 to 2 years’ related( See Definition )


Packaging Operator

A packaging operator uses manual and/or automated packaging systems to label, inspect, and package final container products. He or she also enters data and imprints computer-generated labels, maintains records, and maintains the manufacturing/ production area to comply with regulatory requirements, good manufacturing practices, and standard operating procedures. A packaging operator may also perform initial checks( See Definition )


Patent Administrator

A patent administrator is responsible for preparing and coordinating all procedural documentation for patent filings and applications. He or she tracks in-house research studies and recommends the need for and timing of patent filings. A patent administrator also assists attorneys with the drafting and editing of patent applications and collects and evaluates supporting data. This( See Definition )


Patent Agent

A patent agent is responsible for preparing, filing, and processing patent applications for the company. He or she negotiates and drafts patent licenses and other agreements. A patent agent also conducts state-of-the-art searches and may assist with appeal and interference proceedings. A patent agent also performs other duties as required. The entry-level patent agent position( See Definition )


Plant Breeder

A plant breeder is responsible for the design, development, execution, and implementation of plant breeding research projects in collaboration with a larger research team. He or she may be responsible for project planning and personnel management within the project. Plant breeders may use exotic germ plasm and work with various mating systems and integrate them( See Definition )


Postdoctoral Fellow

The postdoctoral fellow, with a Ph.D. but little or no job experience, joins the staff for a maximum of two to three years to gain necessary experience before moving onto a more senior scientist position.( See Definition )


Process Development Associate

A process development associate is responsible for the implementation of production procedures to optimize manufacturing processes and regulatory requirements. He or she may also assist in process development, in creating scalable processes with improved product yield and reduced manufacturing systems costs. A process development associate, at the entry level, may also be involved in packaging( See Definition )


Product Development Engineer

A product development engineer, at the entry level, is responsible for the design, development, modifications to, and enhancements of existing products and processes. The position is involved in new product scale-up, process optimization, technology transfer, and process validation. He or she ensures that processes and design implementations are consistent with good labor and manufacturing practices.( See Definition )


Production Planner Scheduler

A production planner scheduler is responsible for planning, scheduling, and coordinating the final approval of products through the production cycle. He or she coordinates production plans to ensure that materials are provided according to schedules to maintain production and provides input to management. When necessary, a production planner scheduler works with the Customer Service, Marketing,( See Definition )


Quality Assurance Auditor

A quality assurance auditor is responsible for performing audits of production and quality control. He or she ensures compliance to in-house specifications, standards, and good manufacturing practices. The job requires a bachelor of science degree in a scientific discipline or equivalent and a minimum of 0 to 2 years’ experience in biological or pharmaceutical manufacturing.( See Definition )


Quality Control Analyst

A quality control analyst is responsible for conducting routine and nonroutine analysis of raw materials. He or she compiles data for documentation of test procedures and reports abnormalities. A quality control analyst also reviews data obtained for compliance with specifications and reports abnormalities. He or she revises and updates standard operating procedures and may perform( See Definition )


Quality Control Engineer

A quality control engineer is responsible for developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. He or she designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and prepares documentation for inspection testing procedures. Depending on the job level,( See Definition )


Regulatory Affairs Specialists

A regulatory affairs specialist, at the entry level, coordinates and prepares document packages for submission to regulatory agencies, internal audits, and inspections. He or she compiles all material required for submissions, license renewals, and annual registrations. An incumbent monitors and improves tracking and control systems and keeps abreast of regulatory procedures and changes. He or( See Definition )


Research Assistant

The job description for a research assistant is similar to that of a research associate. At the entry level, the job can require a bachelor of science or advanced degree in a scientific discipline or equivalent, with little or no related experience.( See Definition )


Research Associate

A research associate is responsible for research and development in collaboration with others on projects. He or she makes detailed observations, analyzes data, and interprets results. Research associates prepare technical reports, summaries, protocols, and quantitative analyses. An incumbent maintains familiarity with current scientific literature and contributes to the process of a project within his or( See Definition )


Sales Representative

A sales representative is responsible for direct sales of company products or services. He or she calls on prospective customers, provides product information and/or demonstrations, and quotes appropriate customer prices. A sales representative is also responsible for new account development and growth of existing accounts within an established geographic territory. A sales representative must meet( See Definition )


Scientific Programmer Analyst

Scientific programmer analysts design, develop, evaluate, and modify computer programs for the solution of scientific or engineering problems and for the support of research and development efforts. He or she analyzes existing systems and formulates logic for new systems. A scientific program analyst also devises logical procedures, prepares flow charts, performs coding, tests, and debugs( See Definition )


Systems Analyst

A systems analyst is responsible for system level software and for maintenance of the operating system(s), various layered products, system tuning, and various levels of user assistance. The systems analyst is responsible for the operation of all system software, performing upgrades, and maintaining related system and user documentation. He or she assists in the impementation( See Definition )


Technical Recruiter

A technical recruiter is responsible for recruiting, interviewing, and screening applicants for technical exempt and nonexempt positions. He or she coordinates preemployment physicals, travel, reporting dates, security clearances, and employment processing for new hires. He or she also conducts employee advertising and reviews employment agency placements. In addition, a technical recruiter maintains college recruiting, affirmative( See Definition )


Technical Services Representative

A technical services representative provides technical direction and support to customers on the operation and maintenance of company products. He or she also serves as a contact for customers on technical and service-related problems. A technical services representative also demonstrates uses and advantages of products. An entry-level technical services representative position requires an associate’s degree( See Definition )


Technical Writer

An entry-level technical writer is responsible for writing and editing standard operating procedures, clinical study protocols, laboratory procedure manuals, and other related documents. He or she edits and/or rewrites various sources of information into a uniform style and language for regulatory compliance, and assists in developing documentation for instructional, descriptive, reference, and/or informational purposes. An( See Definition )


Validation Engineer

A validation engineer is responsible for the calibration and validation of equipment and systems and for assisting in the selection, specification, and negotiation of competitive pricing of equipment. He or she maintains all of the documentation pertaining to qualification and validation and serves as an information resource for validation technicians, contractors, and vendors. At the( See Definition )


Validation Technician

An entry-level validation technician would be responsible for developing, preparing the installation of, and revising test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices. A validation technician compiles and analyzes validation data, prepares reports, and makes recommendations for changes( See Definition )


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