Laboratory GMP Compliance Coordinator

• 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.

· 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.

Knowledge, Skills and Abilities:

• 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)

The hourly pay range estimated for this position based in New Jersey is $25.00-$31.00. 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: https://jobs.thermofisher.com/global/en/total-rewards