Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Shift: Full-Time; Monday – Friday; 7am-3pm EST
ONSITE:
This is a fully onsite role based at our customer’s site in King of Prussia, PA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
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.
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 customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage 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.
Key responsibilities:
As a Sr. Logistics Coordinator you will provide resources to execute the Sterile Operations, Sample Management and Logistics functions in Upper Merion building 29, which will have accountability for the following activities: Able to perform all technical operations in area of assignment at a high level of proficiency, such as logging in materials, inspection for damage and cold chain compliance, maintaining inventory records, sampling of raw materials, and updating materials in conformity to GMP standards.
Ensures materials are stored in appropriately identified manner in suitable environment.
Ensures inventory records are maintained according to procedural requirements.
Performs packaging of materials for shipment with minimal supervision.
Contributes to the creation and revision of Material specifications, accession control forms and SOPs.
Maintains and oversees housekeeping of the area and restocking of general supplies.
Coordinates and manages transfer of excipients, components, and samples to support clinical and pre-clinical manufacture and component processing orders.
Manage inventories and schedule activities appropriately.
Contributes to relevant investigations.
Assist in the preparation of metrics and key KPIs for the area.
Able to identify and coordinate implementation of safety, quality, and business improvements.
FSP FTE will lead department consumables storage and stocking programs.
FSP FTE may be asked to lead administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.
All job functions will be performed according to procedure and in accordance with cGMPs, Standard Operating Procedures, and client safety codes and regulations.
Identifies potential risks to the business for consideration by management.
Lead and contribute to GMP and safety self-inspection activities in area of responsibility.
Accountable for reporting and maintaining metrics as appropriate.
Zero instances of data falsification or data integrity issues by PPD staff.
FSP FTE has basic computer skills including Word, Outlook, and ability to navigate simple website interfaces.
When performing manufacturing operations, FSP FTE will be expected to wear appropriate gowning (scrubs, hair net, beard cover, gloves, safety glasses, safety shoes), stand for periods of time, and operate standard pharmaceutical manufacturing equipment.
FSP FTE must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents.
When performing manufacturing operations, FSP FTE may not wear jewelry, makeup, perfume, nail polish, or have artificial nails. Flat wedding bands and medical alert bracelets are accepted.
FSP FTE may be asked to work occasional overtime hours.
Must be a committed team player prepared to work in and embrace a team-based culture.
Act as a Lead SME on upgrades/transition of Inventory Management System used by the Sterile Operations team to support business processes/activities (e.g. COMET to SAP, etc)
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2-4 years).
In some cases an equivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, Global Quality Policies (GQP 3201A (Document Management and Control) and GQP 3201B (Data Management and Control)) and supporting business procedures.
Proactively communicates the status of critical compliance systems support and problem resolution. Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of Sterile Ops management.
Applies metric generation and reporting for Sterile Ops led processes.
Leads by example in working collaboratively and embracing Client’s Code of Conduct to effectively implement solutions. Develops and maintains mutually productive relationships in the workplace. Builds and leverages their own networks of expertise formed with other senior internal and external personnel for the benefit of the team.
Leads the identification and implementation of strategies to improve the qualities and efficiencies of Sterile Ops processes, systems and results. Maintains strong systems/processes understanding of current technologies and professional concepts.
Responsible for scheduling and planning work to meet priorities set by the Client. Sets specific daily and weekly priorities to meet timelines. Recommends procedures and policies to supervision.
Working Environment:
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!