Shire Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

Summarized Purpose: Ensures timely and accurate completion of day-to-day laboratory work. Performs a wide variety of low, moderate and high complexity clinical laboratory testing within a variety of studies over various therapeutic areas. Responsible for maintenance of the equipment. Maintains the sample processing unit.

Essential Functions:

• Performs clinical laboratory testing on samples according to established laboratory procedures and verifies/reports test results as requested by study protocol.

• Performs a wide variety of testing, including but not limited to serology-based testing, pregnancy testing, urinalysis, KOH prep and TV rapid testing.

• Utilizes department protocols to undertake procedures to a consistently high standard.

• Accurately performs quality control/assurance and proficiency testing as needed.

• Uses the equipment as per the operating procedures monitoring and reporting faults to the relevant personnel.

• Ensures control of the laboratory environment, safety specifications and the maintenance and calibration of laboratory material required to conduct clinical trials.

• Maintains accurate freezer logs, temperature monitoring logs, specimen labelling and documentation. • Assists with sample shipment (packing, documentation, organization with courier) and ensures the good quality of the shipment.

• Maintains confidentiality in relation to all information regarding patients.

• Provides support and reassurance to patients, taking into account their physical and psychological needs.

• Ensures quality at the site, adherence to ICH/GCP, SA GCP guidelines, GCLP guidelines and LQMP and adherence to COP’s, SOP’s.

• Note: Some tasks listed above only to be conducted as per country regulations and with relevant valid qualifications/ certification or supervision.

Job Complexity: Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.

Job Knowledge: Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks.

Supervision Received: Normally receives little instruction on daily work, general instructions on newly introduced assignments.

Business Relationships: Contacts are frequent with individuals representing other departments, and / or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function, or the department, or which may be of sensitive nature.

Qualifications:

Education and Experience:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

• Technical positions may require a certificate

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years). \

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Strong phlebotomy skills or willingness to learn

• Good medical terminology and ability to perform conducting of vital signs

• Strong understanding of quality compliance and Good Clinical Practices (GCP), with ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs

• Basic computer skills, including proficiency with Microsoft Office, and capable of learning new software/hardware

• Good attention to detail

• Good problem-solving abilities

• Good organizational and time management skills with the ability to multitask and oversee numerous studies with a variety of therapeutic areas and sizes simultaneously

• Strong oral and written communication skills, including the use of Business English • Skilled in all types of audit preparations and oversight during audits

• Good interpersonal, leadership and consultative skills

• Familiarity with archival processes and systems

Management Role: No management responsibility

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.

• Occasional drives to site locations.

• Potential Occasional travel required.

Physical Requirements:

• Frequently stationary for 4-6 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.

• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO & Affirmative Action

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.