GMP/Pharma Manufacturing Operator (2nd Shift)(ONSITE)

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