HPLC Analyst at Eurofins Lancaster Laboratories Professional Scientific Services, LLC in Foster City, California

Job Description:

HPLC Analyst




Employee Responsibilities:

• Independently plans and executes that support research, development and validation activities


• Support cGMP testing activities by performing analytical methods including UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration.


• Perform data analysis and troubleshoot methods and instrumentation


• Write and execute study plans, validation protocols and reports


• Prepare data for presentation and assist in generating technical reports, and interact with other groups within the department


• Participate in user requirements, assessment and validation of 21 CFR Part 11 software and/or customized software plus authoring SOPs, User Manuals and Training Documentation


• Perform review and peer review of analytical data


• Initiate and perform investigations and development as needed

The Ideal Candidate would possess:

• Demonstrated success in GMP regulated analytical environments


• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, Dissolution, Thermogravimetric DSC/TGA, and KF titrations


• Knowledge in Lab information System and Part 11 software (e.g. Empower, LES, ELN, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance


• Knowledge in Compliance System (e.g. GTrack, GxP Learn, EDMS and RDMS)


• Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience


• Ability to communicate complex scientific findings and recommendations in one-on-one discussions and departmental meetings


• Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs


• Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment


• Strong computer, scientific, and organizational skills


• Excellent attention to detail; excellent project management skills including the ability to manage ones project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management


• Ability to work independently and as part of a team with internal and external clients, self - motivation, adaptability, and a positive attitude


• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Minimum Qualifications:

• 
  B.S. and 3-5 years of experience or M.S., 2-4 years of experience in an analytical GMP regulated environment


• Experience with HPLC/UPLC required
  
• Knowledge of Empower processing software, a plus


• Authorization to work in the United States indefinitely without restriction or sponsorship

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options


• Life and disability insurance


• 401(k) with company match


• Paid vacation and holidays

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Foster City, California are encouraged to apply.

Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.


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