(Senior) Manufacturing QA specialist

Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com

We are looking for two new team members. Join us!

As a manufacturing QA specialist in our department, you have the opportunity to work closely with manufacturing departments related to producing different kind of intermediates and finished products used for in vitro diagnostic of cancer.

We focus on good collaboration between line of business and QA. Therefore, we spend a lot of time performing tasks such as QA presence and “go-look-see” as well as participating in early involvement in different cases such as nonconformities, changes, validations and projects. Producing reagents for in vitro diagnostic of cancer is not as simple task so we are constantly required to find a way through the jungle of good manufacturing practice, authorities’ expectations and securing products to patients as fast as possible.

Key Responsibilities:

• Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
• Make decisions on quality & compliance issues with little guidance.
• Ensure site compliance with Regulations, ISO standards, local standard operating procedures (SOPs).
• Serve as the Subject Matter Expert (SME) of the multiple quality processes.
• Lead improvement activities/improvement of standards within quality management system.
• Support, review & approve complex cross-functional investigations & root-cause analysis.
• Facilitate sharing of regulatory & compliance expectations.
• Facilitate presentation & support for audits & inspections.
• Eliminates non-value-added practices.

Qualifications

• Bachelor’s or master’s degree in a Quantitative/Scientific/Technical discipline.
• +2 years of work experience in the medical device or pharmaceutical industry
• Preferably experience working with In Vitro Diagnostic and/or Medical Devices
• Strong knowledge and understanding of standards and regulations: ISO 13485, Regulation (EU) 2017/746, ISO 14971:2019 and regulations covered under MDSAP
• LEAN mindset.
• Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
• Strong verbal and written communication skills
• Results oriented and willing to take accountability.
• Thrive working cross-functionally with people at all levels of the organization
• Flexible, systematic, and engaged team player
• Full fluency to read/write/speak in English on a business level.

• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.

We offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing, and sustain activities.
• An opportunity to make a significant impact and develop your skills in a world-class company that takes pride in developing innovative solutions for pathology labs worldwide to improve cancer diagnostics.
• A role among passionate colleagues, in a growth-oriented and inclusive environment. You will become part of a caring and fast-paced environment, built on integrity, sharing, and trust.
• Core global benefits, including the Agilent Result Bonus and Stock Purchase Plan.

 Please note Job level will be adjusted according to relevant experience and qualifications.

Additional Details

Travel Required

Shift

Duration

Job Function

Location: Denmark-Glostrup

Additional location:

• Denmark -  Hovedstaden - Copenhagen

(Senior) Manufacturing QA specialist

Job Description

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com

We are looking for two new team members. Join us!

As a manufacturing QA specialist in our department, you have the opportunity to work closely with manufacturing departments related to producing different kind of intermediates and finished products used for in vitro diagnostic of cancer.

We focus on good collaboration between line of business and QA. Therefore, we spend a lot of time performing tasks such as QA presence and “go-look-see” as well as participating in early involvement in different cases such as nonconformities, changes, validations and projects. Producing reagents for in vitro diagnostic of cancer is not as simple task so we are constantly required to find a way through the jungle of good manufacturing practice, authorities’ expectations and securing products to patients as fast as possible.

Key Responsibilities:

• Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
• Make decisions on quality & compliance issues with little guidance.
• Ensure site compliance with Regulations, ISO standards, local standard operating procedures (SOPs).
• Serve as the Subject Matter Expert (SME) of the multiple quality processes.
• Lead improvement activities/improvement of standards within quality management system.
• Support, review & approve complex cross-functional investigations & root-cause analysis.
• Facilitate sharing of regulatory & compliance expectations.
• Facilitate presentation & support for audits & inspections.
• Eliminates non-value-added practices.

Qualifications

• Bachelor’s or master’s degree in a Quantitative/Scientific/Technical discipline.
• +2 years of work experience in the medical device or pharmaceutical industry
• Preferably experience working with In Vitro Diagnostic and/or Medical Devices
• Strong knowledge and understanding of standards and regulations: ISO 13485, Regulation (EU) 2017/746, ISO 14971:2019 and regulations covered under MDSAP
• LEAN mindset.
• Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
• Strong verbal and written communication skills
• Results oriented and willing to take accountability.
• Thrive working cross-functionally with people at all levels of the organization
• Flexible, systematic, and engaged team player
• Full fluency to read/write/speak in English on a business level.

• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.

We offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing, and sustain activities.
• An opportunity to make a significant impact and develop your skills in a world-class company that takes pride in developing innovative solutions for pathology labs worldwide to improve cancer diagnostics.
• A role among passionate colleagues, in a growth-oriented and inclusive environment. You will become part of a caring and fast-paced environment, built on integrity, sharing, and trust.
• Core global benefits, including the Agilent Result Bonus and Stock Purchase Plan.

 Please note Job level will be adjusted according to relevant experience and qualifications.

Additional Details

Travel Required

Shift

Duration

Job Function

Location: Denmark-Glostrup

Additional location:

• Denmark -  Hovedstaden - Copenhagen