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Please note that this is a 1 year contract position.
This position is Monday-Friday, 6:00 am to 2:30pm.
EDUCATION AND EXPERIENCE:
Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience
High School diploma required.
This position is responsible for performing manufacturing procedures and executing diverse tasks in manufacturing related to Donor Screening, Antisera and Red Cell processes in the Packaging manufacturing lines 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 EHS guidelines.
ESSENTIAL FUNCTIONS:
Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
Inspect products on line to confirm proper assembly and remove defective products
Use of ERP system for performing material transactions/moves/quantities/cycle counts
Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
Verify and enter production parameters per SOP and Batch Records.
Work with Shift Leader and Production Planner to review departmental production schedules, work orders and related information to ensure materials and resources are available for production. Reviews progress reports concerning production status and downtime of equipment and communicates issues effectively with peer team, Team Leader, mechanics, and engineers and quality partners. Demonstrate positive team-oriented approach in the daily execution of procedures. Communicate and provide feedback on operators/technicians performance to Team Leader.
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
Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.
Wear the appropriate PPE when working in manufacturing and other working environments.
May perform other duties as assigned.
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 & 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:
Report to work on-time and according to the shift schedule.
Perform other duties as assigned.
Attend departmental and other scheduled meetings.
Practice good interpersonal and communication skills.
Demonstrate positive team-oriented approach in the daily execution of procedures.
Promote and work within a team environment
Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
Assist with validation activities in the area
AUTONOMY and COMPLEXITY:
Needs some direction to perform manufacturing daily tasks within functional area.
Performs and has good understanding of processes and procedures.
Assist with validation activities within the area.
Notifies Shift Leader or Supervisor of maintenance and/or repairs needed on manufacturing equipment or processes
May assist in troubleshooting of routine manufacturing equipment/ processes
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 supervision
COMPUTER 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 system
LANGUAGE SKILLS:
Ability to read, write and speak English
Read and interpret documents such as safety rules, operating instructions and logbooks
Review and provide feedback for SOP and Batch Record Revisions
Good communication and written skills
PHYSICAL DEMANDS:
While performing the duties of this job, the employee:
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.
Work with blood, blood products and chemicals
Overtime is required, as necessary
Shift work may be required, as necessary
Periodic exposure to 2-8C temperature controlled coldbox during product transfer
Applicants must provide their phone number. Reference job number A3439.
NetSource, Inc.
