Lab Project Associate II

Job Title

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.

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.

Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious 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:

• 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

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