Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.
Labs FSP - Sterile Manufacturing Operator
Share job link
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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.
Perform all tasks assigned per Sterile Manufacturing Operator job description which includes, but is not limited to:
• 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.
• Store materials in appropriately identified manner in suitable environment.
• Maintain inventory records.
• Performs packaging of materials for shipment with minimal supervision.
• Contributes to the creation and revision of Material specifications, accession control forms and SOPs.
• Maintains housekeeping of the area and restocking of general supplies.
• Coordinates 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.
• Employee will participate in department consumables storage and stocking programs.
• Employee may be asked to perform 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 safety codes and regulations.
• Identifies risks to business for consideration by management.
• Assist and contribute to GMP and safety self-inspection activities.
• Accountable for reporting and maintaining metrics as appropriate.
• Zero instances of data falsification or data integrity issues by PPD staff.
• Employee has basic computer skills including Word, Outlook, and ability to navigate simple website interfaces.
• When performing manufacturing operations, employee 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.
• Employee must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents.
Education and Experience:
High school diploma or GED
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-1+ years).
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:
Knowledge of applicable regulatory authority, compendia and ICH guidelines
Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use
Ability to utilize Microsoft Excel and Word to perform tasks
Ability to independently optimize analytical methods
Good written and oral communication skills
Time management and project management skills
Problem solving and troubleshooting abilities
Ability to work in a collaborative work environment with a team
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.
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!
Recibe notificaciones de trabajos similares
¡Error!
Recomendaciones de perfil
Trabajos similares
-
Scientist- HPLC
Ubicación Collegeville, Pensilvania, Estados Unidos Id. del empleo R-01306461
Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biologi...
-
Scientist, Particle Size
Ubicación Collegeville, Pensilvania, Estados Unidos Id. del empleo R-01303595
Perform complex laboratory activities, including sample analysis. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or a MS...
-
Scientist - Solid State Characterization
Ubicación Boston, Massachusetts, Estados Unidos Id. del empleo R-01309384
Support solid state characterization and method development, validation and execution for pharmaceutical materials across the discovery and development pipeline. Scientist: Previous experience that pr...
-
Senior Scientist - Quality Control Lab
Ubicación Boston, Massachusetts, Estados Unidos Id. del empleo R-01308743
Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’). OR Masters degree and previous experience that provides the knowledge, s...
-
Assistant Scientist - Dry Lab
Ubicación Richmond, Virginia, Estados Unidos Id. del empleo R-01309593
Trains on SOPs, regulatory procedures and guidelines as assigned. Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable...
-
Scientist - HPLC, GC, KF
Ubicación Boston, Massachusetts, Estados Unidos Id. del empleo R-01302280
The ability to work successfully in both a team/matrix environment as well as independently. The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple proj...
-
Scientist - Gas Chromatography
Ubicación Boston, Massachusetts, Estados Unidos Id. del empleo R-01306361
Maintains general lab equipment, GCs and HPLCs. Demonstrates knowledge of scientific principles and basic understanding of applicable drug development regulations. Scientist: Previous experience that...
-
Senior Scientist
Ubicación Richmond, Virginia, Estados Unidos Id. del empleo R-01308963
Bachelor's degree or equivalent and relevant formal academic / vocational qualification and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+...
-
Senior Scientist - Stability Testing, GMP
Ubicación Boston, Massachusetts, Estados Unidos Id. del empleo R-01301282
In addition, this role will be responsible for supporting various GMP stability testing programs and Quality Systems, including handling stability Quality Events, performing stability testing, deliver...
Los solicitantes de empleo también vieron
Nos aseguraremos de que las personas con discapacidades reciban adaptaciones razonables para participar en el proceso de solicitud de empleo o entrevista de trabajo, para que puedan ejercer las funciones de trabajo esenciales y recibir otros beneficios y privilegios del empleo. Comuníquese con nosotros para solicitar una adaptación.