Overview
Skills
Job Details
Please note that this is a 1-year contract.
This role will be 2nd Shift 3pm 11:30PM / M F
Requirements:
GMP document experience.
High School Diploma required; Bachelor s Degree preferred
3+ years of experience in medical device or pharmaceutical manufacturing
Experience using SAP is preferred
Proficient with using MS Office (Word, Excel, Outlook)
Strong mechanical problem-solving ability and technical aptitude
Ability to work independently with limited supervision and work as part of a team
Able to solve practical/complex problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to demonstrate flexibility and adaptability, as well as prioritize within a changing business environment
Must pass vision acuity test for inspection of work in process and finished goods
Ability to occasionally lift up to 40lbs
Strong communication, intrapersonal and written skills
This position is responsible for performing manufacturing procedures and executing diverse tasks in a manufacturing area related to Filling.
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 (Environmental, Health, and Safety)
We are seeking a Manufacturing Operator II.
This position is responsible for performing manufacturing procedures and executing diverse tasks in a manufacturing area related to Filling.
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.
The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment.
The employee is 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.
Is frequently required to communicate with coworkers.
Ability to lift up to 40lbs.
Work with blood, blood products and chemicals.
Periodic exposure to 2 8 C temperature controlled cold box during product transfer.
Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum
Accurately complete documentation in batch records, logbooks, forms and other GMP documents
Sets up and operates production equipment to produce work in process and finished goods
Take samples for further downstream testing and perform tests during processing according to standard procedures
Check products on line to confirm proper assembly and remove defective products
Cleans, maintains, and performs basic repairs on equipment as needed
Use of ERP system for performing material transactions/moves/quantities/cycle counts
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
Overtime is required, as needed
Needs to perform gowning procedures to work in manufacturing core or classified rooms
While performing the duties of this job, the employee is 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 be able to lift bulks, place on mixer and attach tubing to filling machine
Close Visual Acuity (Visual inspection for small defects or parts, extensive reading or analyzing data)
Intermediate Visual Acuity (operating machines, computer terminal or work at or within arm's reach)
Perform other work-related duties as assigned
Applicants must provide their phone number. Reference job number A4847.