FSP Scientist Analytical Chemistry Lab Instrument Support

Work Schedule

Environmental Conditions

Job Description

Shift: Full-Time; Monday Friday; 8am-5pm PT

ONSITE:

This is a fully onsite role based at our customers site in South San Francisco CA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States withoutsponsorship.

Must be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll 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.

Thermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate deliberate and driven by our mission to enable our customers to make the world healthier safer and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers organizations to provide long-term support. Through this collaborative approach our professionals bring their commitment to excellence industry knowledge and operational strength directly into customer environments helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

• Initiate and maintain the lifecycle of multiple analytical instruments used in testing synthetic molecules. The lifecycle includes initial qualification calibration preventative maintenance troubleshooting and repair and decommissioning of analytical instrumentation.
• Provide support to multiple laboratories by ordering supplies managing inventories coordinating vendor visits and helping to maintain GMP status for analytical instrumentation.
• Provide documentation support in the form of proof-reading formatting document control (Condor) and technical writing. Document Control Specialist will support documentation needs for controlled documents throughout the creation revision and final approval process
• Act as a change owner (Trackwise/Veeva) to create change control records for analytical equipment and documents and review of proposed changes to documents to ensure traceability throughout the document change control process
• Ensure on-time completion of all routine activities related to instrument lifecycle (e.g. preventative maintenance activities) and change records.
• Ensure all work is completed efficiently under GMP compliance to maximize operations.
• Help ensure laboratory compliance by performing routine walk-throughs to detect and mitigate potential environmental health and safety issues

Education and Experience:

• Bachelors degree in lab sciences such as Chemistry Biochemistry Material Science Immunology Biology Molecular Biology or similar
• Assoc Scientist: Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0-2 years)
• Scientist: Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2-4 years)
• OR Masters degree

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:

• Experience in the qualification calibration maintenance and troubleshooting of GMP instrumentation including but not limited to HPLC GC LCMS dissolution testers titrators and FTIR.
• Experience with Document Control processes preferred
• Strong word processing and proofreading skills a must.
• Extensive knowledge/experience using MS Word.
• Experience with Change Records (Trackwise/Veeva) strongly preferred
• Basic understanding of change control process
• Exceptional attention to detail and turnaround time
• Strong understanding of regulatory requirements around FDA 21 CFR Part 11 EU Annex 11 GAMP 5 GLP and GMP regulations as well as ISO 9001 QMS requirements. Experience working with lab systems (ELN LIMS Empower Chemstation) and processes in a GxP environment is highly desirable
• Experience serving and developing a strong partnership with clients in a fast-paced environment
• Laboratory support for analytical chemistry laboratories
• Ability to work independently or as part of a team utilizing self-motivation adaptability and a positive attitude
• Strong computer skills. Strong Windows OS and permissions skills a plus
• proactive communication (oral and written); excellent organizational skills including the ability to manage project resource requirements (material time etc.) and ability to elevate relevant issues to appropriate leadership
• Ability to learn new techniques perform and prioritize multiple tasks simultaneously keep accurate records follow instructions and comply with company policies and procedures
• Excellent judgment troubleshooting and problem solving skills
• Familiarity with risk based assessments and decision making is highly desirable

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: job posting is for multiple levels: