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Manufacturing Operator

Saint Paul, MN 55118

Posted: 04/22/2022 Employment Type: Direct Hire Category: Manufacturing Job Number: 62198 Pay Rate: 52,000

Job Description


Job Summary:

Responsible for assisting with production line set up, tear down, and routine operation of pharmaceutical manufacturing processes on commercial scale equipment. This includes following current Good Manufacturing Practices (cGMPs) and   standard operating procedures. It also includes documenting in manufacturing records using Good Documentation Practices (GDPs).

 

Duties/Responsibilities:

 
  • Demonstrate the necessary technical abilities related to the operation of commercial.

equipment. This includes:
    • Gaining and applying the necessary technical aptitude related to mixing, coating, slitting, rotary converting, and packaging, as necessary.
    • Learning and retaining key technical concepts (as applicable) required for the converting.

production lines. This includes web handling, tensions, gear ratios, splices, die stations, vision systems, pick-in-place systems, etc.
    • Learning and retaining the key technical concepts (as applicable) required for the mixing.

and coating production lines. This includes order of additions, solvation, emulsions, coat. weights, % solids, assay, viscosity, etc.
    • Provide adequate support to the manufacturing line Lead. This includes monitoring the process, performing roll changes, in-process inspections, line set-up, line tear-down, applicable cleaning, and other production responsibilities as deemed necessary or as assigned.
    • Independently operating small presses (Webtron, Allied, Packaging Equipment)

 
  • Perform necessary job functions, including assisting the Lead operator, per .

standards and policies to ensure the product Quality targets and specifications are met. This includes:
    • Documenting all manufacturing records in compliance with ALCOA and Good Documentation Practices (GDP).
    • An understanding of and compliance with   cGMP requirements. This includes, staying current with training and following proper gowning, safety, and controlled substance policies and procedures.
    • Demonstrate ability to read, comprehend, and accurately complete manufacturing documents such as Manufacturing Batch Records (MBRs), Set up diagrams (SUDs), Visual Standards, Control Charts, Summary Sheets, Reconciliation Forms, Logbooks, etc.
    • Performing proper line clearances and material returns as required.
    • Communicating issues and solutions in a professional manner, particularly during shift changeovers.

 
  • Abides by, and contributes to, the   Continuous Improvement and Safety Initiatives. This includes:
    • Identifying and reporting potential safety hazards.
    • Ensuring safety equipment is functioning properly before using.
    • Following all safety policies and procedures.
    • Contributing to the safety culture by reporting close calls, performing safety and 6S audits routinely.
    • Participation in the continuous improvement and change processes. Identifying and

Created: 4-15-20      Revised: 4-12-21

 

submitting continuous improvement (CI) recommendations.

 
  • Overall and other duties as assigned.
    • Responsible for acting consistently with   core values of Excellence, Integrity and Community. 
    • Fosters team environment where other are treated professionally and respectfully. - Maintain a positive attitude. Keeps self and team motivated.

 

Education and Experience:
  • High School diploma or GED. (Technical or Associates degree preferred)
  • 0-3 years working in a cGMP production environment. (1+ years preferred)
  • Strong ability to understand written and verbal instructions in English language required.

 
  DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.   We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.   Apply today and experience “ The DAVIS Difference”. 
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As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.