Manufacturing Operator - Somerville, United States - Caresoft Inc.

Caresoft Inc. Somerville, United States

2 weeks ago

Description

Job Description

Job DescriptionTitle:
Manufacturing Operator

Location:
Raritan NJ

Duration: 12 Months

POSITION SUMMARY:

This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to Filling, Labeling and Line Tending according to detailed operational specifications and execution of scheduled tasks within a cGMP environment.

Ensure materials are available to meet production schedule.

This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.

Accountable for adhering to all EHSguidelines.*ESSENTIAL

FUNCTIONS:

Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
Support schedule adjustments to meet production, material receipt and shipping requirements.

Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for production.

Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations
Sets up and operates production equipment to produce work in process and finished goods
Perform in-process testing as required by processes and procedures utilizing equipment such as: (Fillers, Labelers, autoclave, oven, torque testers, scales and printers) list is not all inclusive
Check products on line to confirm proper assembly and remove defective products
Take samples for further downstream testing and perform tests during processing according to standard procedures
Use of ERP system for performing material transactions/moves/quantities/cycle counts
Cleans , maintains, and performs basic repairs on equipment as needed
Operate and troubleshoot equipment in clean room and non-clean room environment
Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.
Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
Verify and enter production parameters per SOP and Batch Records.
Monitor environmental conditions inside and outside classified rooms
Wear the appropriate PPE when working in manufacturing and other working environments.
Demonstrate training progression, train designated personnel in all levels of responsibility
Understand Lean principles as it relates to work
Understand Value Stream maps and relevancy
Actively participates in Kaizen, problem solving and asset care

Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve.

Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors*ADDITIONAL RESPONSIBILITIES/DUTIES:

Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield and productivity.

Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.

Adhere to the safety code of Conduct & J&J EHS policies and attend all required EHS training.
Follow Global Leadership Profile (GLP) competencies based on their leadership level within the organization (individual leader)

Support the ongoing production schedule by:
oReport to work on-time and according to the shift schedule.
oPerform other duties as assigned.
oAttend departmental and other scheduled meetings.
oPractice good interpersonal and communication skills.
oDemonstrate positive team-oriented approach in the daily execution of procedures.
oPromote and work within a team environment
oLearn new skills, procedures and processes as assigned by management and continue to develop professionally.
oAssist with validation activities in the area
Responsible for audit preparation and participation*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

NATURE OF TASKS:Good mechanical and troubleshooting knowledge within functional area
Demonstrate a good understanding of the process in order to properly perform the assigned manufacturing tasks
Identify discrepancies or trends that might need additional attention and notifies supervisionCOMPUTER ABILITY:
Good working knowledge and understanding of systems as required.
Utilizes tools within MS Office and other systems to improve business effectiveness.
Accurate Data Entry skills in ERP systemEDUCATION AND

EXPERIENCE:

Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience
HS Diploma or Equivalent required.

OTHER SKILLS, ABILITIES OR QUALIFICATIONS:

Understand Lean principles as it relates to work
Understand Value Stream maps and relevancy
Actively participates in Kaizen, problem solving and asset care PHYSICAL

DEMANDS:

While performing the duties of this job, the employee:

Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.

Is frequently required to communicate with coworkers.

While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time.

Must pass vision acuity test for inspection of work in process and finished goods
Ability to lift up to 40 lbs.
Needs to perform gowning procedures to work in manufacturing core or classified rooms.
Work with blood, blood products and chemicals
Work in a cGMP area and/or clean room environment
Overtime is required, as necessary
Shift work may be required, as necessary

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