97 jobs found in branchburg

RESPONSIBILITIES: Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls. Shift - M/T/W 6:00pm - 7:00am Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards. Follows all department work instructions, SOPs, OSHA safety regulations. Executes all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines. As part of the production team will perform in-process quality checks for specific quality attributes (fill check, seal heights and label alignment check) and defects. Must have the ability to wear protective gowning as manufacturing steps are performed in an environmentally controlled area. Uses basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, etc. Completes necessary manufacturing records legibly and accurately. Executes SAP and...

Production Tech (Diag Tech)- 2nd Shift 3:00pm to 11:30pm Responsibilities: Participates in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits. For participation in Filling Operations, job requirements will include ability to perform aseptic gowning and performing all filling tasks in the aseptic environment. As part of the production team, may perform in-process quality checks for specific quality attributes (Fill Check, Torque check, Vision System Check, Label Alignment Check etc.). Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements. Assists in completing all necessary production documentation (Production Manufacturing Records) and associated SAP transactions to ensure that all components meet requirements...

Typical shift hours are from 7:00am- 3:30pm or may vary due to workload. May need weekend work Responsibilities: Perform production and testing including production support duties for Operations ensuring quality of production and/or lab testing is completed by the department. Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks. Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures. Duties may include handling of hazardous materials in activities described above. Depending upon area of assignment or primary focus, may maintain departmental stock rooms, keep labs stocked, prepare buffers as needed/required which may also include performing direct production...

Equipment Support Specialist/ Calibration Technician Shift Hours: 8:00am- 4:30pm Job responsibilities : Calibrates and performs preventative maintenance on process and laboratory instrumentation/Roche Brand equipment. Meets all schedules for calibrations and preventative maintenance. Notifies Department Management when any instrument/equipment is nonconforming and follows up to ensure a timely response to the issue. Assists/Leads in troubleshooting and/or repairing of instrument or equipment problems and resolving difficult problems in creative ways. Uses discretion and independent judgment to consider and determine appropriate solutions / actions. Performs unscheduled calibration/preventive maintenance activities as needed to support owning departments. Maintains technical department files (e.g. specification sheets, manuals). Maintains department supplies required for performing calibrations/preventive maintenance, as applicable. Coordinates with RMS...

Responsibilities: Prepare validation documents utilizing established and published procedures or batch records and technical and theoretical understanding while managing schedules and work flow to accomplish assigned objectives or schedules. Assumes responsibility for the accuracy, quality, and timeliness of validation documents. Summarizes batch or experimental results, and reviews conclusions with supervisor/project leader. Communicates results of validation activities. Keeps supervisor/project leader informed of work status, particularly of significant findings and results in critical problem areas. Analyzes and interprets test results, experimental data using various data analysis software, spreadsheets and or applying quantitative methods. Uses technical writing skills to produce reports and documents. May present findings at internal meetings. Assumes accountability for batch record, hard copy or electronic lab notebook documentation, ensuring experimental methods and...

1st Shift Position Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls Responsibilities Perform weighing and dispensing of raw materials for process orders, inventory management, and warehouse management following applicable SOPs and Batch records. Perform production and testing including production support duties for Operations ensuring quality of production and/or lab testing is completed by the department. Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks. Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures. Duties may include handling...

Responsibilities: Performing oligonucleotide synthesis by following detailed instructions outlined in production batch records and SOPs using automated equipment combined with benchtop chemistry The candidate will be expected to organize work to ensure efficient utilization of time and materials and to complete all procedures in a cGMP compliant manner The candidate will also be expected to respond quickly and effectively to multiple and changing priorities, and to schedule work effectively to ensure that current and future needs are met The candidate will be required to accurately and consistently record methods, materials, and results in batch records according to established formats and to keep supervisor informed on status of all projects and of significant findings and results in critical areas. Additional Responsibilities: Perform and oversee oligo synthesis production for MCM Operations and ensure quality of production by the department. Performs a...

JOB SUMMARY Responsibilities • Performs, assists with, or coordinates a wide range of operations connected with the installation, removal, repair, alteration and maintenance of all types of mechanic, electrical, plumbing, and other utility systems. • Document Maintenance activities using SAP Plant Maintenance system. Oversee and coordinate the activities of a wide range of Facilities Management service providers. Must carry a cell phone and/or pager and be available to provide 24 hour "on-call" support for site emergencies on a rotating basis as required by local Facilities Management. May be assigned to act as primary or back-up SAP Plant Maintenance Coordinator. • May develop, monitor and control annual budgets for assigned maintenance and repair services. This includes budgets associated with internally performed maintenance and external service providers. May oversee execution of small expense and capital projects as assigned. • Monitor and update as required various...

Shift hours: TH-SAT 6:00pm - 7:00am This position includes a 17% shift differential Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls. RESPONSIBILITIES: Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards. Follows all department work instructions, SOPs, OSHA safety regulations. Executes all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines. As part of the production team will perform in-process quality checks for specific quality attributes (fill check, seal heights and label alignment check) and defects. Must have the ability to wear protective gowning as manufacturing steps are performed in an environmentally controlled area. Uses basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, etc. Completes necessary...

The Summer @ Roche Intern Program has been developed to provide students with a fun yet rewarding summer through hands-on experience and numerous opportunities to network with other interns as well as employees in the organization. Additionally, we help our students meet their career development and educational goals while potentially building a future with the Roche organization. Leveraging the education you received already, we hope to give you an opportunity to grow and develop with us! Program Requirements: Currently enrolled in an accredited college/university during program calendar year 2019 Completed at least 2 years of college/university to be eligible for the program. Must have a ≥3.0 GPA Minimum availability of 12 weeks (Required start on or before program Welcome Reception and end date on or after Summer End Poser Symposium). Previous experience in the job duties listed, either through course work or industry/academia Participation in student organizations...

Production Tech- 2nd Shift 3:00pm to 11:30pm Responsibilities: Participates in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with Production Manufacturing Records, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits. For participation in Filling Operations, job requirements will include ability to perform aseptic gowning and performing all filling tasks in the aseptic environment. As part of the production team, may perform in-process quality checks for specific quality attributes (Fill Check, Torque check, Vision System Check, Label Alignment Check etc.). Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements. Assists in completing all necessary production documentation (Production Manufacturing Records) and associated SAP transactions to ensure that all components meet requirements pertaining...

Shift hours: 11pm - 7:30am ESSENTIAL JOB FUNCTIONS & MAJOR CONTRIBUTIONS Participates within the operation of packaging and labeling and using equipment of varying complexity and in accordance with Production Manufacturing records, applicable SOPs, and ISO and cGMP requirements to produce intermediates and final kits. As part of the production team, may perform in-process quality checks for specific quality attributes (vision system check, label alignment checks, kit inspections, etc.). Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements. Make judgments regarding quality of product and materials. Assists in completing all necessary documentation (Production Manufacturing Records, electronic batch records, required forms, etc.) associated with packaging operations as required. Assists in MRP system transactions to ensure corresponding process orders are completed in a timely manner....

Summary: Responsible for labeling, inspecting and packaging of final container products with manual and/or automated packaging systems from distribution center to customer or clinical trial sites. May also set-up, change-over and operate labeling and packaging equipment. Responsible for data entry and imprinting computer generated labels. Maintains records and manufacturing/production area to comply with regulatory requirements, good manufacturing practices and standard operating procedures. May perform initial check of completed documents for completeness and accuracy. Responsibilities: Performs a variety of duties relating to the receipt, storage, and/or disbursement/delivery of finished goods, raw materials, and other supplies, and equipment. This may include hazardous materials such as solvents, radioactives, etc. Works independently to complete tasks, and records information in a timely and legible manner. Receiving - Oversees the receiving and/or...

1st Shift Position Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls Responsibilities Perform weighing and dispensing of raw materials for process orders, inventory management, and warehouse management following applicable SOPs and Batch records. Perform production and testing including production support duties for Operations ensuring quality of production and/or lab testing is completed by the department. Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks. Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures. Duties may include handling...

This is a one year assignment. Provides scheduling coordination for routine maintenance activities, emergency repairs, planned shutdowns and contract labor for GMP Filling & Packaging Operations. Job Duties: • Orders spare parts and consumable maintenance supplies to support maintenance operations. • Manages spare parts inventory and ensures spare parts are charged to maintenance work orders. • Manages preventive and corrective maintenance monthly backlog to ensure work is completed as scheduled. • Creates notifications and maintenance work orders in SAP PM. • Develops preventive maintenance plans for equipment and works with Mechanical Supervisor to schedule such activities in SAP PM. • Leads maintenance planning meetings to ensure appropriate communication and follow-up across functions. • Project-manage equipment maintenance or equipment project tasks through to completion under minimal to no supervision Skills: SAP planning experience...

Job Responsibilities: Conceives, plans and conducts independent production work or project work from inception through product launch and field support, defining schedules, and applying advanced scientific knowledge to complete projects. Designs experiments to test hypothesis related to project outcomes, and analyzes and interprets data/results. Recommends new or creative approaches, and/or expansion or curtailment of investigations based on experimental data or new scientific information arising from area of responsibility. Participates and leads project planning, production scheduling, process updates, and experimental design. Assumes responsibility for timely completion of projects or assigned work, ensuring activities are consistent with project critical path and responding appropriately to changing priorities. Ensures technical activities under delegated supervision are conducted within internal and external guidelines and regulations (including QSR and FDA regulations)....

Job Description Job Description Responsibilities: Perform production and testing including production support duties for Operations ensuring quality of production and/or lab testing is completed by the department. Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks. Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures. Duties may include handling of hazardous materials in activities described above. Depending upon area of assignment or primary focus, may maintain departmental stock rooms, keep labs stocked, prepare buffers as needed/required which may also include performing direct production or testing activities. Maintain stock rooms and laboratories...

Shift hours: TH-SAT 6:00pm - 7:00am This position includes a 17% shift differential Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls. RESPONSIBILITIES: Performs tube/frame assembly, filling, labeling and pouching operations consistent with Roche quality standards. Follows all department work instructions, SOPs, OSHA safety regulations. Executes all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines. As part of the production team will perform in-process quality checks for specific quality attributes (fill check, seal heights and label alignment check) and defects. Must have the ability to wear protective gowning as manufacturing steps are performed in an environmentally controlled area. Uses basic laboratory equipment to complete manufacturing and filling activities including pipettes, scales, etc. Completes necessary...

Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls. This position is eligible for a shift differential. Responsibilities: Supervises sub-teams of assigned operators to perform filling/packaging/ labeling/label printing and/or visual inspections to complete assigned production operations. The Individual can set-up, troubleshoot, and participate in change overs of Fill/Package/Label equipment as required. Individual is skilled in the set-up and operation of automatic and semi-automatic filling, labeling, and Packaging/warehouse equipment to provide coverage as required to meet production plans. Individual ensures that during every production operation, that all inprocess tests required to be performed by the team (Fill, torque, label alignment) are taken as required and meet predetermined acceptance criteria. Individual will operate specialized laboratory,...

Responsibilities: Provides developmental plans for direct reports and conducts on-going performance management activities. Depending upon primary focus of position, oversees work groups which conduct operations, planning and logistics, manufacturing and other routine activities. Is responsible for the accuracy, quality and timeliness of logistics activities and product supply. Keeps leaders informed of product and project status, particularly of significant observations and results in critical areas. Ensures that work group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO). Serves as a technical resource and mentor to the members of the work group and resolves issues encountered in the logistics and planning processes to improve performance. Provides definition and plans for timely achievement of overall product or project goals and to the expeditious...