Manufacturing Operator

Primary Responsibilities:
The Manufacturing Operator is responsible for performing all necessary tasks within the Manufacturing Suite required for the production of safe and effective pharmaceutical products. THIS JOB IS LOCATED IN TONGANOXIE, KS.

Reports to:
Manager, Manufacturing

Manages others:
No

Specific responsibilities:

• Develop knowledge of and understand regulatory requirements by the FDA, DEA, and other regulatory agencies.
• Understand and follow Standard Operating Procedures (SOP's) and regulations relative to the positions within the manufacturing facility, including the sterile area.
• Participate in all aspects of Manufacturing; as well as record keeping, including but not limited to appropriate batch records and laboratory notebooks / logbooks.
• Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) autoclave, filler / peristaltic pump, capper, labeler, etc.
• Maintain training compliance and assist in training new/less experienced operators.
• Assist in the execution of equipment/process qualification, validation, and protocols.
• Perform cleaning activities in the manufacturing area per established proedures
• Ability to gown and function in a sterile environment
• Work methodically with an acute awareness of the direct and indirect impact of all actions performed and how these actions maintain patient safety .
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Background/Skills:

• High School Diploma or GED required, Associates or undergraduate degree a strong plus

• Ability to follow processes and procedures and solve workflow problems

• Strong Mechanical abilities preferred

• Eager and willing to will teach you

• Ability to pass a background check and drug screening

• Dependable/reliable

• Detail-oriented

Physical Requirements of the Role:

Position requires a significant amount of standing and walking as well as frequent bending over and lifting and carrying up to 50 pounds. Must be able to pass gowning qualification, and wear PPE (including respirator if required). All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.'
'
Work Location:

• One location

Work Remotely:

• No

Job Type: Full-time

Pay: $ $25.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person