Are you ready to play a key role in ensuring quality and compliance in a world-class organization At LGC we are looking for a dedicated QA Labeling Specialist to join our ambitious engineering team. As a part of our growing community you will contribute to projects that impact global health and safety standards. Join us and help us make a difference!
Duties:
- Generate review and approve all QA Labeling documentation with outstanding attention to detail.
- Support all QA labeling projects for the introduction of new products product improvements and labeling master document changes.
- Review and approve lot-specific production labeling to guarantee perfect adherence.
- Populate review and approve instructions for use (IFU) including lot-specific technical data when relevant.
- Complete examine and authorize IFU templates containing the revised lot-specific technical information.
- Populate review and approve lot-specific technical data and upload it to the relevant technical or resource library.
- Process all updated labeling documents through ETQ with proven accuracy.
- Update review and approve changes to the master labeling documents including labels packaging specifications and IFUs.
- Complete verification of master labeling IFU updates on the auto-population electronic IFU software system.
- Upload QA labeling documents and customer communications to the relevant technical or resource library and website.
- Collaborate with applicable functional areas on build control and change control projects related to QA labeling.
- Keep designated areas clean and orderly while adhering closely to all workplace health and safety regulations.
- Perform other related duties as assigned by management.
Qualifications :
Minimum Qualifications:
- Bachelors Degree or equivalent experience in a relevant field.
- Minimum of 2 years of industry experience working in a regulated medical product environment.
- Proficient in Microsoft Word Excel Adobe InDesign and/or NiceLabel Pro software.
Preferred Qualifications:
- Knowledge of FDA 21CFR820 ISO13485 IVDD98/79/EC IVDR EU/2017/746 and international regulatory requirements.
Behavioural & Interpersonal Proficiencies:
- Resonate and operate in line with LGCs core value behaviors: Passion Curiosity Integrity Brilliance and Respect.
- Promote cooperation and dedication within a team to achieve goals and deliverables.
- Strong initiative and troubleshooting skills required.
- Strong interpersonal skills and the ability to communicate well verbally and in writing.
- Strong attention to detail combined with consistently precise work.
- Ability to multitask and determine priorities is essential.
Additional Information :
The customary salary range for this position is:
Minimum pay rate: $60000 USD
Maximum pay rate: $81000 USD
The salary range provided covers the minimum and maximum amounts projected for this role. The base salary will be influenced by factors like experience skills and location.
All your information will be kept confidential according to EEO guidelines.
Join LGC and become part of a team that values collaboration integrity and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.
Our values:
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Equal opportunities
LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age disability race color ethnic or national origin sex sexual orientation gender reassignment marital or civil partnership parental responsibilities religion or belief. Shortlisting interviewing and selection will always be carried out without regard to gender sexual orientation marital status color race nationality ethnic or national origins religion or belief age or trade union membership.
For more information about LGC please visit our website
#scienceforasaferworld
Remote Work :
No
Employment Type :
Full-time
Are you ready to play a key role in ensuring quality and compliance in a world-class organization At LGC we are looking for a dedicated QA Labeling Specialist to join our ambitious engineering team. As a part of our growing community you will contribute to projects that impact global health and safe...
Are you ready to play a key role in ensuring quality and compliance in a world-class organization At LGC we are looking for a dedicated QA Labeling Specialist to join our ambitious engineering team. As a part of our growing community you will contribute to projects that impact global health and safety standards. Join us and help us make a difference!
Duties:
- Generate review and approve all QA Labeling documentation with outstanding attention to detail.
- Support all QA labeling projects for the introduction of new products product improvements and labeling master document changes.
- Review and approve lot-specific production labeling to guarantee perfect adherence.
- Populate review and approve instructions for use (IFU) including lot-specific technical data when relevant.
- Complete examine and authorize IFU templates containing the revised lot-specific technical information.
- Populate review and approve lot-specific technical data and upload it to the relevant technical or resource library.
- Process all updated labeling documents through ETQ with proven accuracy.
- Update review and approve changes to the master labeling documents including labels packaging specifications and IFUs.
- Complete verification of master labeling IFU updates on the auto-population electronic IFU software system.
- Upload QA labeling documents and customer communications to the relevant technical or resource library and website.
- Collaborate with applicable functional areas on build control and change control projects related to QA labeling.
- Keep designated areas clean and orderly while adhering closely to all workplace health and safety regulations.
- Perform other related duties as assigned by management.
Qualifications :
Minimum Qualifications:
- Bachelors Degree or equivalent experience in a relevant field.
- Minimum of 2 years of industry experience working in a regulated medical product environment.
- Proficient in Microsoft Word Excel Adobe InDesign and/or NiceLabel Pro software.
Preferred Qualifications:
- Knowledge of FDA 21CFR820 ISO13485 IVDD98/79/EC IVDR EU/2017/746 and international regulatory requirements.
Behavioural & Interpersonal Proficiencies:
- Resonate and operate in line with LGCs core value behaviors: Passion Curiosity Integrity Brilliance and Respect.
- Promote cooperation and dedication within a team to achieve goals and deliverables.
- Strong initiative and troubleshooting skills required.
- Strong interpersonal skills and the ability to communicate well verbally and in writing.
- Strong attention to detail combined with consistently precise work.
- Ability to multitask and determine priorities is essential.
Additional Information :
The customary salary range for this position is:
Minimum pay rate: $60000 USD
Maximum pay rate: $81000 USD
The salary range provided covers the minimum and maximum amounts projected for this role. The base salary will be influenced by factors like experience skills and location.
All your information will be kept confidential according to EEO guidelines.
Join LGC and become part of a team that values collaboration integrity and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.
Our values:
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Equal opportunities
LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age disability race color ethnic or national origin sex sexual orientation gender reassignment marital or civil partnership parental responsibilities religion or belief. Shortlisting interviewing and selection will always be carried out without regard to gender sexual orientation marital status color race nationality ethnic or national origins religion or belief age or trade union membership.
For more information about LGC please visit our website
#scienceforasaferworld
Remote Work :
No
Employment Type :
Full-time
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