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.
