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QA Specialist - III

In California / United States

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QA Specialist - III   

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JOB TITLE:

QA Specialist - III

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Frederick California / United States

JOB DESCRIPTION:

Description:

Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
Coordinate and facilitate Quality Assurance related production and production related activities, including:
o Issuance of electronic batch records and manufacturing labels.
o Assessment and closure of discrepancies, deviations and change controls requests.
o Assessment and closure of laboratory investigations.
o Timely assessment and closure of batch and material hold events.
o Communicate lot disposition pending issues to management.
o Review of batch manufacturing and testing documentation for timely delivery of final product.
Ensure that tests are performed and products are manufactured in compliance with Client specifications, regulatory and GMP guidelines.
Support development of SOPs and review/approve SOPs to ensure quality objectives are met
Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
Review and approve manufacturing production records.
Compile and verify all batch related documents into a final product lot disposition package.
Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
o Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
o Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
o Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.
Review and disposition raw materials, components, and labels for GMP use.
Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
Manage and participate in internal, external and regulatory inspections and audits at the site.
Perform other duties as required.

Job will entail Grade B/C gowning.

Job may require weekend/holiday work.

Position Details

POSTED:

Jun 24, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204865030843606

LOCATION:

California / United States

CITY:

Frederick

Job Origin:

CEIPAL_ORGANIC_FEED

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

QA Specialist - III    Apply

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Description:

Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.
Coordinate and facilitate Quality Assurance related production and production related activities, including:
o Issuance of electronic batch records and manufacturing labels.
o Assessment and closure of discrepancies, deviations and change controls requests.
o Assessment and closure of laboratory investigations.
o Timely assessment and closure of batch and material hold events.
o Communicate lot disposition pending issues to management.
o Review of batch manufacturing and testing documentation for timely delivery of final product.
Ensure that tests are performed and products are manufactured in compliance with Client specifications, regulatory and GMP guidelines.
Support development of SOPs and review/approve SOPs to ensure quality objectives are met
Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.
Review and approve manufacturing production records.
Compile and verify all batch related documents into a final product lot disposition package.
Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.
o Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
o Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.
o Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA.
Review and disposition raw materials, components, and labels for GMP use.
Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
Manage and participate in internal, external and regulatory inspections and audits at the site.
Perform other duties as required.

Job will entail Grade B/C gowning.

Job may require weekend/holiday work.


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