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Manufacturing Operator II - NJ Manufacturing Operator II - NJ

Company: Abacus Service Corporation
Location: Raritan
Posted on: January 27, 2023

Job Description:


Skills

No record(s) found.



Education

No record(s) found.



Job Description & Requirements



Job Type:
Recruited Resource - General Temp
Number of Positions:
1


System Location:
OCD - 6118
Created Date:
11/30/2022


Job Title:
Manufacturing Operator II - NJ




CWR Type:
W-2
Reason:
Resignation/Open Position





Qualifications:




Manufacturing Operator II - Donor Screening ELISA Plate Processing - See Attached Job Description.

Responsibilities:




Manufacturing Operator II - Donor Screening ELISA Plate Processing - See Attached Job Description.

Attached Documentation:






Attachment

11/30/2022 1:51 PM (EST)
Joanne Lagno










Requestor & Work Location




Requested by:
N/A
Alternate:
N/A


Report To:
N/A




Phone:
N/A Ext.:N/A




Travel Required:

How Much Travel?



Report To Manager's Office Address
1001 US Highway 202 USRAR, Raritan, NJ 08869 United States


Start Date:
12/27/2022
Work Days:




Sun
Mon
Tue
Wed
Thu
Fri
Sat























































End Date:
12/29/2023


Start Time:
8:00 AM
Total Reg Hours:
40.00


End Time:
4:30 PM
Overtime Required:



Lunch Time:
30 Minutes




Exempt:

Open Bid:







Attachment:

Manufacturing Operator II - Donor Screening ELISA Plate Processing



Position Summary:



Donor Screening Kits for ELISA Test Systems include the following seven components that are product-specific: positive control, negative control, conjugate-antibody, antigen-coated microwell plates, specimen diluent, substrate buffer and o phenylenediamine 2-HCI tablets. This results in multiple manufacturing sub-processes inclusive of the formulation and testing of multiple bulk reagents and the manufacturing of antigen-coated microwell plates.



This position is responsible for executing diverse tasks related to Donor Screening ELISA Plate Production. All duties are performed according to detailed operational specifications within a cGMP manufacturing environment. This position is responsible for maintaining the highest standards in compliance and quality within company policies, procedures, and all applicable regulations.



Duties and Responsibilities:



  • Executes manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum. Demonstrates knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.
  • Maintains accurate, complete and timely written batch records and documentation. Perform batch record review of documents as needed.
  • Use of ERP system for performing material transactions/moves/quantities/cycle. counts/scrap/usage decisions. Use of System to perform data input and investigations.
  • Identify and assist in resolving discrepancies or trends that might need additional attention and follows up with supervision.
  • Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
  • Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
  • Understand Lean Principles as it relates to work. Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve.
  • Review and revise BTRs, SOPs, etc. for accuracy.
  • Quality and Regulatory Compliance including (1) reviews and resolutions of non-conformances, (2) audit preparation and participation; and (3) understanding and utilization of the Quality Management systems to support production compliance.
  • Demonstrate training progression through assigned curriculum.
  • Assists with schedule updates in coordination with team members and management.



    Qualifications:


    • High School Diploma required, Associates degree or Bachelor's degree preferred.
    • Minimum of 2 years experience in manufacturing within a regulated industry (medical device, pharmaceutical or equivalent.)
    • Strong communication and analytical skills required.
    • Mechanical aptitude and competence required.
    • Computer aptitude and competence required.





Keywords: Abacus Service Corporation, Trenton , Manufacturing Operator II - NJ Manufacturing Operator II - NJ, Other , Raritan, New Jersey

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