Packaging Operator II

Location: Bedford, MA

Position Scope:

The Packaging Operator II will perform intermediate packaging, sterilization, and cartoning operations to meet commercial product demands. The position follows established procedures and documents work in batch records and forms.   

Specific Tactical Responsibilities:

  • Performs cGMP functions associated with manual/automated packaging operations including visual inspection, pouching, labeling, and cartooning
  • Adjust equipment settings for start-up in accordance to Standard Operating Procedures (SOPs)
  • Understands and adheres to SOPs
  • Performs room sanitization activities to maintain controlled environment conditions
  • Documents work activities in controlled documents according to Good Documentation Practices
  • Reports procedural deviations and nonconformance to management
  • Maintains current training on all assigned procedures to include read & understood, skills development, and classroom training activities as required
  • Perform other job related duties as assigned

Job Complexity:

The position works on equipment and assignments where adherence to proper safety and cGMP procedure is required in order to perform work activities.  The Packaging Operator II works on assignments semi-routine in nature, following established procedures and executes routine 5S tasks with limited instruction.

Supervisory Responsibilities:

None

Required Qualifications:

  • Minimum High School Diploma or GED equivalency
  • 2 – 4 years or related experience in a regulated environment
  • Experience with cGMPs and Good Documentation Practices
  • The ability to read, write and verbally communicate in English
  • The ability to work flexible hours to complete work activities

Desired Experience, Knowledge, and Skills:

  • Experience working in a clean room environment packaging medical devices or drug products  
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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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