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Manufacturing Operator

2 months ago

Irvine, United States Siegfried Irvine Full time

Manufacturing Operator for Medical Device - 2nd Shift Position (2:00 PM - 10:30 PM)

This position requires knowledge and ability to perform duties related to the manufacturing of drug, aseptic, device and assembled products utilizing reliable methods according to established procedures. Responsible for performing various duties in the manufacturing, inspection and documentation of producing such products.
- **Responsibilities**_
- Completes training modules regarding gowning techniques for the entrance to and from designated areas.
- Ability to assess the process being performed to ensure consistent quality product is being delivered.
- Ability to perform product visual inspection through a use of a high magnification microscope to ensure product meets specification criteria. Ability to demonstrate a high level of detail to determine acceptability.
- Technical ability to operate a 200X magnification microscope.
- Ability to demonstrate the use of a robotic arm and set the appropriate technical parameters.
- Train new hires and/or associates when needed and is able to clearly communicate the activities to be performed.
- Ability to demonstrate the use of small tools to manually assemble a hand piece delivery device in accordance with company procedure.
- Demonstrate the ability to formulate pharmaceutical grade drug product with strict adherence to company procedure.
- Ability to demonstrate the use of an Analytical and/or Micro Balance and have a clear understanding of weight values such as grams, milligrams and micrograms.
- Ability to demonstrate and operate use of equipment as required.
- Ensures good documentation practices in the recording of data, organizing of batch records, forms, logbooks and any other associated documents for responsible areas.
- Assists other team members in manufacturing areas when needed.
- Maintain good work place organization and housekeeping.
- Responsible for adhering to applicable FDA, SOPs, cGMP and ISO clean room manufacturing rules and regulations related to the position.
- **Required Knowledge, Skills and Abilities**_
- Ability to read, write and communicate in English to the extent necessary to perform the job function
- Good team and problem solving skills
- Ability to demonstrate manual dexterity
- Ability to stand continuously for two or more hours
- Ability to work safely with moving equipment.
- Ability to calculate proportions and simple mathematical skills.
- Ability to work overtime as necessary
- **Required Education and Experience**_
- High school graduate or equivalent
- 3+ years of Pharmaceutical / Medical Device industry required

Pay Range: $25-26/hour + 10% Shift Differential when working on 2nd Shift

Pay: $25.00 - $26.00 per hour

Expected hours: No less than 40 per week

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- Monday to Friday
- Overtime

Ability to Relocate:

- Irvine, CA 92618: Relocate before starting work (required)

Work Location: In person

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