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Manufacturing Associate I

In California / United States

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Manufacturing Associate I   

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JOB TITLE:

Manufacturing Associate I

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Fremont California / United States

JOB DESCRIPTION:

Duties:
This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly packaging in designated manufacturing area.



Specific to the Assembly and Packaging area, this includes, but is not limited to:

Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine
Movement of product and components within the assembly and packaging area
Transfers product, components and equipment within the CNC area.
Assists with the equipment changeover
Assists with minor equipment repairs/adjustments
Assists in the identification & correction of problems to prevent down-time
Communication and hand-off to relief personnel during shift change as appropriate
Assists in the assembly and packaging operation
Assists the Sr. Associate and / or Master Associate with assembly and packaging set up. This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities. Retrieves components and equipment from storage.
Assists the Sr. and Master Associate with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues.
Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements.
Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes log books, as required.
Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations.
Skills:
Demonstrated ability to be organized and work well in small work groups.
Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
Demonstrated written and verbal communication skills are required.
Must be able to work in a team environment.
Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, working with hands inside an Isolator, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
Level of Proficiency - Entry level in subject matter
Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
To remain in this position, employees:
Must obtain & maintain qualifications, as required, to perform the assigned work.
Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
Education:
Bachelors’ degree, preferably in a science or engineering field.
In lieu of a Bachelor's degree, will consider a minimum of three years closely related experience in a GMP or clean room assembly environment with an Associates Degree or six (6) years closely related experience in a GMP or clean room assembly environment with a High School Diploma or equivalent


Position Details

POSTED:

Sep 03, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16571844090401194

LOCATION:

California / United States

CITY:

Fremont

Job Origin:

Jobsrus_organic_feed

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Manufacturing Associate I    Apply

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Duties:
This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly packaging in designated manufacturing area.



Specific to the Assembly and Packaging area, this includes, but is not limited to:

Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine
Movement of product and components within the assembly and packaging area
Transfers product, components and equipment within the CNC area.
Assists with the equipment changeover
Assists with minor equipment repairs/adjustments
Assists in the identification & correction of problems to prevent down-time
Communication and hand-off to relief personnel during shift change as appropriate
Assists in the assembly and packaging operation
Assists the Sr. Associate and / or Master Associate with assembly and packaging set up. This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities. Retrieves components and equipment from storage.
Assists the Sr. and Master Associate with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues.
Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements.
Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes log books, as required.
Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations.
Skills:
Demonstrated ability to be organized and work well in small work groups.
Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
Demonstrated written and verbal communication skills are required.
Must be able to work in a team environment.
Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred
Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software
Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, working with hands inside an Isolator, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
Level of Proficiency - Entry level in subject matter
Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
To remain in this position, employees:
Must obtain & maintain qualifications, as required, to perform the assigned work.
Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures
Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’s
Education:
Bachelors’ degree, preferably in a science or engineering field.
In lieu of a Bachelor's degree, will consider a minimum of three years closely related experience in a GMP or clean room assembly environment with an Associates Degree or six (6) years closely related experience in a GMP or clean room assembly environment with a High School Diploma or equivalent



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