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Manufacturing Operator

Phoenix, AZ

Posted: 07/27/2022 Job Number: 21260353

Job Description

Onsite position.

Project Description:
  • The Operator I is responsible for executing production activities required to successfully manufacture sterile injectable products.
  • This is accomplished by ensuring equipment, materials, and other resources are in place to meet production demands.
  • The Operator I demonstrate and assures production activities within manufacturing operations are executed following all GMP's.
  • In addition, work will be performed in complete accordance with all SOPs, Specifications, Batch Records, regulatory expectations, and company policies.
  • Accomplishes manufacturing activities per detailed procedural guidance with a demonstrated attention to detail.
  • Performs handling of hazardous materials in compliance with site, industry, local, and federal regulations.
  • Maintains manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.
  • Executes specialized responsibilities mandated by detailed written procedures, site, industry, local, and federal regulations.
  • Assures and completes detailed documentation that is a correct and accurate record.
  • Addresses procedural /documentation errors expeditiously and effectively.
  • Continuously updates job knowledge by participating in job specialized training requirements.
  • Participates as a contributing member in CI projects.
  • Consistently projects a positive attitude and example for other department team members/operators to emulate.
  • Performs other tasks as assigned.

Required Skills:
  • High school diploma or equivalent required.
  • 1 year of relevant work experience required, preferably in a regulated and/or pharmaceutical environment.
  • An equivalent combination of education/experience may substitute.
  • Robust functionality in Microsoft Applications and other computer-based systems utilized in the manufacturing department (i.E. MES, HMI's, etc.).
  • Demonstrated proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.
  • Intermediate written and verbal communication skills within the department and with support groups.
  • Functional job specific proficiency in mathematics.
  • Practical understanding of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.
  • Ability to pass a full physical including a respiratory certification with annual monitoring.
  • Ability to stand up to 8 hours/day, utilizing controlled movements.
  • Aptitude to use hand tools in the setup and troubleshooting of specialized manufacturing equipment.
  • Ability to execute complex activities both independently and in a team environment.
  • Full face respirator may be required for certain activities.
  • The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. For 8 hours, approximately 5 times per week.
  • The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day.
  • The incumbent may be in a standing position for at least 8 hours per day.
  • This position will require overtime, shift work, and flexibility in scheduling of " set shift hours at times, based on production demands or extraordinary circumstances.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Joanne: jm@alphaconsulting.Com


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Joanne Magno

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