PDS Tech Commercial, Inc.
Cell Management Specialist
PDS Tech Commercial, Inc., Morris Plains, New Jersey, United States, 07950
Cell Management Specialist
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** 2 Openings **
Location:
Morris Plains, NJ - work is ONSITE Start:
ASAP Shift:
Rotational shift - Days: Tuesday - Saturday or Sunday - Thursday Contract Length:
12 months to start Pay:
$24.91 - $27.53 per hour (depending on experience)
The Cell Management Specialist is responsible for Apheresis Receipt, Final Product Packaging (FPP), Day 0 and Harvest transfers. Inventory Management and other duties required to support the core functions.
Key Responsibilities: • Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance • Ensure timely and accurate data entry • Maintain training compliance • Ensure Manufacturing Support areas are maintained in an “audit ready” state • Provide “flow to the work” support when required/available • Ensure equipment cleaning and maintenance is performed per governing SOP requirements • Escalate any observed compliance or safety issues and support reconciliation of event • Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc. • Support monthly and annual cycle count • Support all site/team projects and initiatives • Act in accordance with Novartis Values and Behaviors Dispensary Activities • Ensure accurate SAP/MES inventories are maintained for all components • Ensure proper status segregation and storage of all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest Activities: • Receipt and inspection of incoming Leukapheresis • Final product packaging and shipping • On time delivery of scheduled Day 0 apheresis for patient processing • Receipt and storage of final product from scheduled patient processing • Follow-up communication to resolve outstanding issues with internal and external customers • Coordination of shipping, receiving, storage and processing of goods. May include imports/exports. • Ensure inventory accuracy of GMP and non-GMP LN2 storage locations • Ensure all materials and documentation is available and accurate so not to impede daily activities
Role Requirements: • 1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred. • High School degree required. Bachelor's degree preferred. • Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required. • Must be well organized, flexible and work with minimal supervision. • Ability to lift up to 50 lbs., assisted. • Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.
Rotational shift: Days: Tuesday - Saturday or Sunday - Thursday
Pay Details:
$24.91 to $27.53 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
https://www.pdstech.com/candidate-privacy
/> The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance
-
** 2 Openings **
Location:
Morris Plains, NJ - work is ONSITE Start:
ASAP Shift:
Rotational shift - Days: Tuesday - Saturday or Sunday - Thursday Contract Length:
12 months to start Pay:
$24.91 - $27.53 per hour (depending on experience)
The Cell Management Specialist is responsible for Apheresis Receipt, Final Product Packaging (FPP), Day 0 and Harvest transfers. Inventory Management and other duties required to support the core functions.
Key Responsibilities: • Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance • Ensure timely and accurate data entry • Maintain training compliance • Ensure Manufacturing Support areas are maintained in an “audit ready” state • Provide “flow to the work” support when required/available • Ensure equipment cleaning and maintenance is performed per governing SOP requirements • Escalate any observed compliance or safety issues and support reconciliation of event • Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc. • Support monthly and annual cycle count • Support all site/team projects and initiatives • Act in accordance with Novartis Values and Behaviors Dispensary Activities • Ensure accurate SAP/MES inventories are maintained for all components • Ensure proper status segregation and storage of all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest Activities: • Receipt and inspection of incoming Leukapheresis • Final product packaging and shipping • On time delivery of scheduled Day 0 apheresis for patient processing • Receipt and storage of final product from scheduled patient processing • Follow-up communication to resolve outstanding issues with internal and external customers • Coordination of shipping, receiving, storage and processing of goods. May include imports/exports. • Ensure inventory accuracy of GMP and non-GMP LN2 storage locations • Ensure all materials and documentation is available and accurate so not to impede daily activities
Role Requirements: • 1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred. • High School degree required. Bachelor's degree preferred. • Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required. • Must be well organized, flexible and work with minimal supervision. • Ability to lift up to 50 lbs., assisted. • Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.
Rotational shift: Days: Tuesday - Saturday or Sunday - Thursday
Pay Details:
$24.91 to $27.53 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
https://www.pdstech.com/candidate-privacy
/> The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance