Quality Assurance Specialist/Quality Complaint Specialist - cGMP/FDA
Des Plaines, IL Des Plaines, IL Contract Contract $36 - $38 an hour $36 - $38 an hour 9 hours ago 9 hours ago 9 hours ago Job description for Quality Assurance Professional We are seeking a high energy Quality Assurance Professional for our client based in Des Plaines, IL Location.
Our client is one of the top Pharma companies in the USA.
Summary Perform a wide variety of activities to support the Quality Management System.
Essential Duties and Responsibilities.
Responsible for activities related to supplier evaluation and supplier performance monitoring and improvements.
Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements.
Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs.
Main Responsibilities oManage reagent and commodity supplier investigations, action plans, effectivity checks, and other documentation.
oApproves components for use in products by driving Production Part Approval activities oSupports supplier change notification process and process improvement efforts.
oSupports the evaluation and development of Supplier Quality Agreements.
oSupports incoming Non-Conforming Material Report (NCMR) activities and related record evaluation with notifications.
oMay support molding qualifications.
Minimum Requirements:
Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
At least 7 years work experience in Quality or related field experience; Has a history of completing successful projects and driving positive compliance outcomes.
Preferred:
oBachelor's or master's degree in one of the following Engineering disciplines:
Chemical, Electrical, Bio-medical, or Mechanical o7
years of relative professional work experience in Medical Device Quality or in a regulated industry (Ex.
:
Automotive) oDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 oStrong technical writing skills; Polished verbal and written communication skills and experience with Trackwise.
Job Type:
Contract Pay:
$36.
00 - $38.
00 per hour Experience level:
1 year Schedule:
8 hour shift Work setting:
In-person Ability to commute/relocate:
Des Plaines, IL:
Reliably commute or planning to relocate before starting work (Required)
Experience:
Nonconformance/CAPA processes:
3 years (Preferred) Non-Conforming Material Report (NCMR):
3 years (Preferred) FDA, GMP, ISO 13485, and ISO 14971:
3 years (Preferred) Medical Device Quality Systems, Quality engineering:
3 years (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
Our client is one of the top Pharma companies in the USA.
Summary Perform a wide variety of activities to support the Quality Management System.
Essential Duties and Responsibilities.
Responsible for activities related to supplier evaluation and supplier performance monitoring and improvements.
Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements.
Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs.
Main Responsibilities oManage reagent and commodity supplier investigations, action plans, effectivity checks, and other documentation.
oApproves components for use in products by driving Production Part Approval activities oSupports supplier change notification process and process improvement efforts.
oSupports the evaluation and development of Supplier Quality Agreements.
oSupports incoming Non-Conforming Material Report (NCMR) activities and related record evaluation with notifications.
oMay support molding qualifications.
Minimum Requirements:
Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
At least 7 years work experience in Quality or related field experience; Has a history of completing successful projects and driving positive compliance outcomes.
Preferred:
oBachelor's or master's degree in one of the following Engineering disciplines:
Chemical, Electrical, Bio-medical, or Mechanical o7
years of relative professional work experience in Medical Device Quality or in a regulated industry (Ex.
:
Automotive) oDetailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 oStrong technical writing skills; Polished verbal and written communication skills and experience with Trackwise.
Job Type:
Contract Pay:
$36.
00 - $38.
00 per hour Experience level:
1 year Schedule:
8 hour shift Work setting:
In-person Ability to commute/relocate:
Des Plaines, IL:
Reliably commute or planning to relocate before starting work (Required)
Experience:
Nonconformance/CAPA processes:
3 years (Preferred) Non-Conforming Material Report (NCMR):
3 years (Preferred) FDA, GMP, ISO 13485, and ISO 14971:
3 years (Preferred) Medical Device Quality Systems, Quality engineering:
3 years (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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