Sr. Scientific Support Specialist – Manufacturing Media/Buffer Prep Specialist
Thermo Fisher
Summary
Join us as a Laboratory Associate – And leverage your experience to oversee complex clinical trials, ensure compliance with protocols, manage data collection, mentor junior staff, and contribute significantly to the success of our research initiatives.
Job description
What You'll Do
- Perform clinical laboratory testing on samples according to established laboratory procedures and verifies/reports test results as requested by study protocol.
- Perform a wide variety of testing, including but not limited to serology-based testing, pregnancy testing, urinalysis, KOH prep and TV rapid testing.
- Utilize department protocols to undertake procedures to a consistently high standard.
- Accurately perform quality control/assurance and proficiency testing as needed.
- Use the equipment as per the operating procedures monitoring and reporting faults to the relevant personnel.
- Ensure control of the laboratory environment, safety specifications and the maintenance and calibration of laboratory material required to conduct clinical trials.
- Maintain accurate freezer logs, temperature monitoring logs, specimen labelling and documentation.
- Assist with sample shipment (packing, documentation, organization with courier) and ensure the good quality of the shipment.
- Maintain confidentiality in relation to all information regarding patients.
- Provide support and reassurance to patients, taking into account their physical and psychological needs.
- Ensure quality at the site, adherence to ICH/GCP, SA GCP guidelines, GCLP guidelines and LQMP and adherence to COP's, SOP's.
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
- 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
Requirements
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- Previous experience comparable to at least 4 years
- Good medical terminology and ability to perform conducting of vital signs
- Strong understanding of quality compliance and Good Clinical Practices (GCP)
- 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
- Good attention to detail
- Good problem-solving abilities
- Good organizational and time management skills
- 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
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- Paid Time Off
- Paid Holidays
- Paid Parental Leave
- Accident Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- 401(k) Retirement Plan
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.