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Batch Record Reviewer II

In California / United States

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Batch Record Reviewer II   

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JOB TITLE:

Batch Record Reviewer II

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Fremont California / United States

JOB DESCRIPTION:

Duties:
This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met. The position performs logistical duties related to batch record review.

Independently executes (paper/electronic) batch record review

- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.

Skills:
Demonstrated proficiency in MS Office programs and associated computer programs.
Technical knowledge of manufacturing systems, methods and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes
Education:
Requires a Bachelors degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment.
In lieu of a Bachelor's degree, will consider an Associate's degree plus 4 years of professional experience in a GMP environment environment or clean room assembly environment.


Position Details

POSTED:

Aug 27, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S1656428406969168

LOCATION:

California / United States

CITY:

Fremont

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Batch Record Reviewer II    Apply

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Duties:
This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met. The position performs logistical duties related to batch record review.

Independently executes (paper/electronic) batch record review

- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.

Skills:
Demonstrated proficiency in MS Office programs and associated computer programs.
Technical knowledge of manufacturing systems, methods and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes
Education:
Requires a Bachelors degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment.
In lieu of a Bachelor's degree, will consider an Associate's degree plus 4 years of professional experience in a GMP environment environment or clean room assembly environment.



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