Analytical Technology Specialist

SmartRecruiters, Inc.; Westport; On-site; EUR 45,000 - 65,000; Full time

Job summary

AbbVie is seeking a qualified QC Bioassay professional to support timely, compliant testing and investigations in accordance with GMP and regulatory requirements. The role involves releasing finished product QA/QC analyses, method validation support, and data integrity in all lab activities.

The candidate will work within a team, contribute to reagent qualifications, and participate in root cause investigations while maintaining safety, accuracy, and proper documentation.

Qualifications

• Minimum requirement of Bachelor of Science. Qualifications in a biological field are preferable.
• Previous GxP experience is preferable but not required.
• Sound scientific/practical understanding of ELISA based methods.
• Knowledge and practical experience in HPLC and UV techniques is preferable.
• Knowledge of method development and validation preferable.
• Practical experience of mammalian cell culture and basic techniques (Passaging, freeze-down, drug treatments) is an advantage.

Responsibilities

• Perform QC release analysis of commercial finished product as per schedule and in accordance with regulatory requirements.
• Perform QC stability analysis as per schedule and in accordance with regulatory requirements.
• Document all laboratory testing activities, results and raw data contemporaneously, accurately and legibly.
• Adherence to all company standards in the areas of safety, housekeeping and quality, notifying management of any discrepancies.
• Contribute to routine lab duties such as critical reagent qualifications, inventory management and equipment maintenance.
• Support Root Cause Analysis investigations where required.
• Develop proficiency in all laboratory IT systems required by QC Bioassay
• Develop the skills required to review and interpret test results via established standards and requirements.

Skills

Data Integrity

Communication

Organization

Time Management

Teamwork

Problem Solving

Technical Writing

Right First Time

Education

Bachelor of Science

Tools

ELISA

HPLC

UV Techniques

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The role supports the timely and compliant delivery of commercial drug product testing and ad hoc investigation and development testing in accordance with approved procedures, GMP and applicable regulatory requirements. As a member of the laboratory team the incumbent will be required to demonstrate the prescribed laboratory values and standards and escalates any technical or quality matters appropriately. The position may also contribute to critical reagent screening and qualification, laboratory housekeeping, documentation review, procedural updates, investigations, and the execution or support of analytical method transfers and validations based on training and demonstrated skill level.

• Perform QC release analysis of commercial finished product as per schedule and in accordance with regulatory requirements.
• Perform QC stability analysis as per schedule and in accordance with regulatory requirements.
• Document all laboratory testing activities, results and raw data contemporaneously, accurately and legibly.
• Adherence to all company standards in the areas of safety, housekeeping and quality, notifying management of any discrepancies.
• Contribute to routine lab duties such as critical reagent qualifications, inventory management and equipment maintenance.
• Support Root Cause Analysis investigations where required.
• Develop proficiency in all laboratory IT systems required by QC Bioassay
• Develop the skills required to review and interpret test results via established standards and requirements.

Qualifications

Education and Experience

• Minimum requirement of Bachelor of Science. Qualifications in a biological field are preferable.
• Previous GxP experience is preferable but not required.
• Sound scientific/practical understanding of ELISA based methods.
• Knowledge and practical experience in HPLC and UV techniques is preferable.
• Knowledge of method development and validation preferable.
• Practical experience of mammalian cell culture and basic techniques (Passaging, freeze-down, drug treatments) is an advantage.

Key Skills, Experience, and Competencies

• Knowledge and understanding of Data Integrity from Laboratory perspective.
• Excellent communication, organization, time management and teamwork skills.
• Basic statistical knowledge is advantageous.
• Proven ability to work on one’s own initiative with a focus on Right First Time (RFT).
• Ability to solve problems through timely communication and collaboration.
• Technical writing ability.
• Demonstrated ability to support priority projects to meet timelines

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.