Clean Room Manufacturing Operator - Integra LifeSciences
Plainsboro, NJ
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION
The warehouse Associate/ Manufacturing operator will verify and keep records of all incoming and outgoing shipments, physically move material to all required inventory locations, and perform all associated transactions in ORACLE. The warehouse associate will perform all required duties in compliance with company policies, U.S. Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactory.
+ Work with internal and external parties to insure the proper items are received in a timely manner and documented.
+ Verifies all incoming materials and paperwork against purchase orders, notifies Buyer of any missing documentation, damages, shortages, and problem receipts.
+ Performs receipt transactions and material moves ensuring receipt and inventory accuracy in ORACLE.
+ Process all required receiving paperwork; affix all appropriate labeling to stock items.
+ Sort and distribute miscellaneous items received to appropriate individuals or departments.
+ Prepare and pack case and pallet size shipments and all associated documentation as per written standard operating procedures.
+ Pick material work orders to be delivered to shop floor.
+ Stock all warehouse and KANBAN locations. Move materials as necessary to maintain neat, organized warehouse.
+ Perform inventory counts and cycle counts dictated by established periodic schedule.
+ Drive the company vehicle.
+ Other related duties as assigned in support of department/organizational duties and initiatives.
+ Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
+ Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
+ Responsible for the cross linking, cutting, packaging and boxing of the product in its finished goods form, which includes performing visual product and component inspections to identify and remove defects.
+ Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
+ Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
+ Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
+ Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
+ Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
+ Responsible for reporting all discrepancies to the Supervisor or Group Leader.
+ Support department and plant Safety goals by continuously demonstrating safe behavior.
+ Maintain a clean and orderly work area.
+ Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.
+ Perform other manufacturing activities as assigned by the department leadership.
+ Primary responsibilities are to:
+ Work with internal and external parties to insure the proper items are received in a timely manner and documented appropriately.
+ Verifies all incoming materials and paperwork against purchase orders, notifies Buyer of any missing documentation, damages, shortages, and problem receipts.
+ Performs receipt transactions and material moves ensuring receipt and inventory accuracy in ORACLE.
+ Process all required receiving paperwork; affix all appropriate labeling to stock items.
+ Sort and distribute miscellaneous items received to appropriate individuals or departments.
+ Work with internal and external parties to insure the proper items are shipped in a timely manner and documented appropriately.
Minimum Qualifications:
·High School diploma or equivalent
+ Minimum1 to 3 years of shipping/receiving/warehouse experience in Pharmaceutical/Medical device environment.
+ Forklift experience
+ Valid drivers license
+ Demonstrated organizational and communication skill.
+ Must possess a team focused attitude.
+ Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, preferred
+ Demonstrated computer skills (MS Office, Excel). Must be capable of working in an Oracle Enterprise Resource Planning (ERP) system.
TOOLS AND EQUIPMENT USED
+ Company Truck
+ Pallet Jack
+ Standing Forklift
+ Commercial shipping software/hardware
+ General office equipment
PHYSICAL REQUIREMENTS
While undertaking the essential duties and responsibilities of the position, the employee must be able to perform basic stock work including bending and reaching, the ability to recognize similarities and differences between words and series of numbers, operate a motor vehicle, sit, listen, speak, and write. The employee is required to go to all areas of the company. The employee is required to lift and/or move up to 75lbs. repeatedly.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
SUMMARY DESCRIPTION
The warehouse Associate/ Manufacturing operator will verify and keep records of all incoming and outgoing shipments, physically move material to all required inventory locations, and perform all associated transactions in ORACLE. The warehouse associate will perform all required duties in compliance with company policies, U.S. Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactory.
+ Work with internal and external parties to insure the proper items are received in a timely manner and documented.
+ Verifies all incoming materials and paperwork against purchase orders, notifies Buyer of any missing documentation, damages, shortages, and problem receipts.
+ Performs receipt transactions and material moves ensuring receipt and inventory accuracy in ORACLE.
+ Process all required receiving paperwork; affix all appropriate labeling to stock items.
+ Sort and distribute miscellaneous items received to appropriate individuals or departments.
+ Prepare and pack case and pallet size shipments and all associated documentation as per written standard operating procedures.
+ Pick material work orders to be delivered to shop floor.
+ Stock all warehouse and KANBAN locations. Move materials as necessary to maintain neat, organized warehouse.
+ Perform inventory counts and cycle counts dictated by established periodic schedule.
+ Drive the company vehicle.
+ Other related duties as assigned in support of department/organizational duties and initiatives.
+ Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
+ Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
+ Responsible for the cross linking, cutting, packaging and boxing of the product in its finished goods form, which includes performing visual product and component inspections to identify and remove defects.
+ Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
+ Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
+ Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
+ Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
+ Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
+ Responsible for reporting all discrepancies to the Supervisor or Group Leader.
+ Support department and plant Safety goals by continuously demonstrating safe behavior.
+ Maintain a clean and orderly work area.
+ Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements.
+ Perform other manufacturing activities as assigned by the department leadership.
+ Primary responsibilities are to:
+ Work with internal and external parties to insure the proper items are received in a timely manner and documented appropriately.
+ Verifies all incoming materials and paperwork against purchase orders, notifies Buyer of any missing documentation, damages, shortages, and problem receipts.
+ Performs receipt transactions and material moves ensuring receipt and inventory accuracy in ORACLE.
+ Process all required receiving paperwork; affix all appropriate labeling to stock items.
+ Sort and distribute miscellaneous items received to appropriate individuals or departments.
+ Work with internal and external parties to insure the proper items are shipped in a timely manner and documented appropriately.
Minimum Qualifications:
·High School diploma or equivalent
+ Minimum1 to 3 years of shipping/receiving/warehouse experience in Pharmaceutical/Medical device environment.
+ Forklift experience
+ Valid drivers license
+ Demonstrated organizational and communication skill.
+ Must possess a team focused attitude.
+ Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, preferred
+ Demonstrated computer skills (MS Office, Excel). Must be capable of working in an Oracle Enterprise Resource Planning (ERP) system.
TOOLS AND EQUIPMENT USED
+ Company Truck
+ Pallet Jack
+ Standing Forklift
+ Commercial shipping software/hardware
+ General office equipment
PHYSICAL REQUIREMENTS
While undertaking the essential duties and responsibilities of the position, the employee must be able to perform basic stock work including bending and reaching, the ability to recognize similarities and differences between words and series of numbers, operate a motor vehicle, sit, listen, speak, and write. The employee is required to go to all areas of the company. The employee is required to lift and/or move up to 75lbs. repeatedly.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences