Eurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for a GMP Training Controller to support our Professional Scientific Services group in Foster City, CA
Scientist/Senior Scientist GMP Training Controller responsibilities include, but are not limited to, the following:
Design and maintain GMP Analytical Chemistry Training Programs for methods such as UPLC/HPLC, Dissolution, GC, DSC/TGA, and KF titration
Monitoring effectiveness of different types of training from role-based, technique and method specific, along with associated curricula, including procedural/read and understand, instructor-led, and On-the-Job Training (OJT) items
Recommend new and innovative solutions to problems utilizing scientific creativity, independent thought and proficiency
Identify technical gaps and make recommendations to continuously improve regulatory compliance
Support the ongoing effectiveness and compliant status of the Training System
Develop training plans for new and existing staff based on their assigned roles and responsibilities
Develop and maintain training content and procedures to enhance the compliance and/ or technical competency of staff and support execution of GMP activities
Collaborate with internal and external (QA, Document Control, etc) customers and stakeholders, as needed, to ensure alignment and effectiveness of training initiatives
Participate, as needed, in investigation activities to determine role of training/human performance factors in discrepancy events
Identify and collaborate to implement effective corrective and preventive actions
Use metrics to determine training effectiveness and identify trends
The ideal candidate would possess:
Demonstrated success training 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
Experience with Empower III software
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 with internal and external clients, and possess 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
Strong focus on quality, teamwork, and productivity
Proactive, positive, solution-oriented leadership style with ability to prioritize and coordinate simultaneous projects with varying deadlines
Strength in employee engagement, morale, and retention
Basic Minimum Qualifications:
B.S. and 4+ years of experience, or M.S and 2+ years of experience
Experience training in an analytical GMP regulated environment
Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday through Friday (8 a.m.-5p.m.), with overtime as needed. Candidates currently living within a commutable distance of Foster City, California are encouraged to apply.
As a Eurofins Lancaster Lab PSS employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
To learn more about Eurofins Lancaster Laboratories, please explore our website www.lancasterlabs.com.
Internal Number: 12051
About Eurofins Lancaster Laboratories, Inc.
Eurofins is the world leader in the food, bio/pharmaceutical product testing. It is also number one in the field of environmental laboratory services and one of the global market leaders in agroscience, genomics, discovery pharmacology, and central laboratory services. With over $2 billion in annual revenues and 25,000 employees across 250 sites in 39 countries, Eurofins is a leading international group of laboratories providing an unparalleled range of testing and support services to the pharmaceutical, biopharmaceutical, food, environmental, and consumer products industries and to governments.