Senior QA Associate
Company Name:
MaxisIT
The Senior QA Associate is responsible in supporting all functional Quality Assurance activities related to the disposition of all client products for clinical and commercial use under the direction of the Senior Manager, QA Product Disposition.
Review and compile executed batch documentation packages for starting materials, intermediates and API for timely disposition of manufactured products for clinical or commercial use.
Support QA members across functional teams communicating effectively with other team members.
Assist in communications with client Subject Matter Experts (SMEs) and contract manufacturing organizations (CMOs) on quality related issues to facilitate corrections, clarifications, and resolution of associated quality issues.
Assist in Quality Investigations of GMP products as required.
Generate Incident Reports, Change Controls and CAPA reports as required.
Update and maintain Quality Assurance Operations logs and databases, and generate metrics as needed.
Oversee and ensure that QA Operations time lines align with supply chain production timelines.
Perform person in plant activities as required and provide QA oversight at CMOs.
Review and verify CMC sections for all regulatory updates and filings as required.
Coordinate and assist in the resolution of moderately complex deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, or any other quality events as directed by QA management.
Coordinate activities for routing QA Operations documents for review and/or approval.
Manage and coordinate activities for special projects (i.e., coordinate, implement, and track activities).
Perform a wide variety of Quality Assurance activities to ensure compliance with applicable US and international regulatory requirements with focus on investigational medicinal products.
Review and improve existing quality procedure workflows and identify areas of improvement for efficiency as needed.
Interact with Technical Operations, Supply Chain, and Regulatory Affairs personnel to ensure that clinical and commercial materials are manufactured in accordance with established procedures and to verify that the accuracy of all project-related CMC information for regulatory filings through various phases of clinical development.
Work
Experience:
Minimum of 4 - 6 years experience in GMP Quality Assurance that support pharmaceutical product development and lot release.
Customer & Industry Knowledge:
Experience with the review and release to US and European countries for all phases of drug development preferred.
Experience interacting with contract manufacturers highly desirable.
Knowledge of Drug Development and Commercial processes preferred.
Must have a complete understanding and application of QA principles, concepts, industry practices, and standards.
Must have the ability to recognize deviation from accepted practice is required.
Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
Working knowledge of cGMPs and the management of Quality Systems that support lot release to US and European countries.
Good working knowledge of Quality Systems and CGMP standards applicable to clinical products.
Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis.
Education/Training:
Bachelors Degree (BA/BS) preferably analytical chemistry or science major, from an accredited college or university
Other Requirements (list any other requirements not identified above, for example, ability to prioritize multiple tasks, ability to work under pressure, ability to work with others, oral or written communication skills, travel requirements, and the like):
Must be able to provide solutions to moderately complex to semi-routine problems.
Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure
Must be highly organized and possess excellent attention to detail.
Motivated, capable of self direction and working autonomously with a proven ability to work in a team environment.
Ability to manage multiple priorities with aggressive timelines at a high level of productivity.
Ability to manage projects and deliver in a timely manner.
Ability to work independently in a high-paced environment with tight timelines, while maintaining accuracy and quality.
Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities.
The best telephone number to reach me is 732-276-9940 Ext: 325. I appreciate if you forward your updated word formatted resume at / for review before we speak.Estimated Salary: $20 to $28 per hour based on qualifications.
MaxisIT
The Senior QA Associate is responsible in supporting all functional Quality Assurance activities related to the disposition of all client products for clinical and commercial use under the direction of the Senior Manager, QA Product Disposition.
Review and compile executed batch documentation packages for starting materials, intermediates and API for timely disposition of manufactured products for clinical or commercial use.
Support QA members across functional teams communicating effectively with other team members.
Assist in communications with client Subject Matter Experts (SMEs) and contract manufacturing organizations (CMOs) on quality related issues to facilitate corrections, clarifications, and resolution of associated quality issues.
Assist in Quality Investigations of GMP products as required.
Generate Incident Reports, Change Controls and CAPA reports as required.
Update and maintain Quality Assurance Operations logs and databases, and generate metrics as needed.
Oversee and ensure that QA Operations time lines align with supply chain production timelines.
Perform person in plant activities as required and provide QA oversight at CMOs.
Review and verify CMC sections for all regulatory updates and filings as required.
Coordinate and assist in the resolution of moderately complex deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, or any other quality events as directed by QA management.
Coordinate activities for routing QA Operations documents for review and/or approval.
Manage and coordinate activities for special projects (i.e., coordinate, implement, and track activities).
Perform a wide variety of Quality Assurance activities to ensure compliance with applicable US and international regulatory requirements with focus on investigational medicinal products.
Review and improve existing quality procedure workflows and identify areas of improvement for efficiency as needed.
Interact with Technical Operations, Supply Chain, and Regulatory Affairs personnel to ensure that clinical and commercial materials are manufactured in accordance with established procedures and to verify that the accuracy of all project-related CMC information for regulatory filings through various phases of clinical development.
Work
Experience:
Minimum of 4 - 6 years experience in GMP Quality Assurance that support pharmaceutical product development and lot release.
Customer & Industry Knowledge:
Experience with the review and release to US and European countries for all phases of drug development preferred.
Experience interacting with contract manufacturers highly desirable.
Knowledge of Drug Development and Commercial processes preferred.
Must have a complete understanding and application of QA principles, concepts, industry practices, and standards.
Must have the ability to recognize deviation from accepted practice is required.
Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
Working knowledge of cGMPs and the management of Quality Systems that support lot release to US and European countries.
Good working knowledge of Quality Systems and CGMP standards applicable to clinical products.
Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis.
Education/Training:
Bachelors Degree (BA/BS) preferably analytical chemistry or science major, from an accredited college or university
Other Requirements (list any other requirements not identified above, for example, ability to prioritize multiple tasks, ability to work under pressure, ability to work with others, oral or written communication skills, travel requirements, and the like):
Must be able to provide solutions to moderately complex to semi-routine problems.
Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure
Must be highly organized and possess excellent attention to detail.
Motivated, capable of self direction and working autonomously with a proven ability to work in a team environment.
Ability to manage multiple priorities with aggressive timelines at a high level of productivity.
Ability to manage projects and deliver in a timely manner.
Ability to work independently in a high-paced environment with tight timelines, while maintaining accuracy and quality.
Excellent attitude with good verbal, interpersonal communication, excellent judgment and multitasking skills who can adapt to changing priorities.
The best telephone number to reach me is 732-276-9940 Ext: 325. I appreciate if you forward your updated word formatted resume at / for review before we speak.Estimated Salary: $20 to $28 per hour based on qualifications.
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