Laboratory GMP Compliance Coordinator

Thermo Fisher Scientific•New Brunswick, NJ

6d•Onsite

About The Position

Thermo Fisher Scientific's 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.

Requirements

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
Experience working in GMP environment- either laboratory setting, manufacturing, or quality/compliance.
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.
Experience in GMP training management and/or GMP documentation is preferred
Writing and reviewing standard operating procedures, experience with change control and deviations/investigation is a plus.
Demonstrated ability to successfully manage competing deadlines and balance priorities.
Excellent technical writing skills, close attention to detail and excellent follow up.
Proficient in Microsoft outlook, word, excel, MS team meetings, SharePoint, Learning Management Systems (LMS), Electronic Document Management Systems (EDMS).
Able to conduct video conference calls via MS teams 4-6 hours a day with team members at different sites. (flexibility for early AM meetings/calls due to time zones)
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.

Nice To Haves

Experience in GMP training management and/or GMP documentation is preferred
Writing and reviewing standard operating procedures, experience with change control and deviations/investigation is a plus.

Responsibilities

Support all aspects of the Documentation and Training Management program for GMP laboratories and supporting functions that support clinical manufacturing.
Responsible for ensuring compliance with company requirements for GMP Documentation and Training Management.
Manage daily service requests for all training related updates in the Learning Management System.
Escalate training related issues promptly and follow through until resolved.
Create and maintain training curricula, and training items.
Create and manage new hire Learning Plans in collaboration with hiring managers.
Support authoring of Documentation and Training content.
Manage training impact assessments for standard operating procedures (SOPs).
Manage training related documentation and approval workflows in the Electronic Document Management Systems (EDMS).
Manage scanning, uploading, and indexing of any paper documentation to the EDMS or submission to documentation storage facility.
Support documentation and training compliance requests for laboratory audits and inspections.
Calculate department training compliance metrics and communicate to management.
Work independently but recognize need to consult stakeholders and keep them informed of progress.
A self-starter with an ability to manage electronic systems, MS outlook and office with minimal training and supervision.

Benefits

competitive remuneration
annual incentive plan bonus
healthcare
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
short- and long-term disability
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