Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Location/Division Specific Information
Thermo Fisher'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 clients to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
This position can be located in either New Brunswick, NJ or Summit, NJ and may require travel between sites. The role is 50% or more onsite with remote opportunities. This role will also require communicating with the Moreton, UK site - requiring flexibility for early AM meetings/calls.
A Day In the Life
Knowledge of electronic document management systems (EDMS) to complete workflow of document to final approval by uploading the word document into EDMS.
Write and revise standard operating procedures (SOPs) for GMP Analytical and Microbiology laboratory operation and instruments. Ability to interview cross functional subject matter experts and translate their description into actionable instructions- Work Instructions, Job Aids using the templates prescribed by corporate policy.
Harmonization of procedures- Schedule cross functional team meetings, collect feedback, create draft documents, post on SharePoint, schedule reviews, collect and resolve feedback.
Propose and obtain endorsement to changes (creation, modification, obsoletion) to procedures based on interviews with personnel.
Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner. Work independently but recognize need to consult stakeholders and keep them informed of progress.
Experience with Learning Management System (LMS) is a plus- Success Factors, Compliance Wire or equivalent training software.
Some experience with conducting lab audits and hosting lab audits is a plus.
A self-starter with an ability to manage electronic systems, MS outlook and office with minimal training and supervision.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
AND 3+ years of previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.
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 environment- either laboratory setting or quality/compliance.
Experience in writing and reviewing standard operating procedures is a must and training management system 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, Share point, electronic document management system (EDMS).
Able to conduct video conference calls via MS teams 4-6 hours a day with team members at different sites.
Able to work 50% on site at New Brunswick, NJ and Summit, NJ locations. This role will also require communicating with our Moreton, UK site and flexibility for early AM meetings/calls is required.
Work Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
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.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
