Laboratory Data Auditor

Job description

Company 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.com.

Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

Purpose

Confirm that analytical and/or microbiological methods and reporting levels are consistent with test methods objectives.

Ensure results are of a level of quality necessary to support sample results by detailed review to ensure reported results have valid laboratory procedures and documentation.

Perform analytical and/or microbial test, documentation, instrument maintenance and routine monitoring as necessary.

Responsibilities

List up to 10 main responsibilities for the job.

Include information about the accountability and scope.

+ Perform analytical and/or microbial tests for the raw materials, finished products and tests for environmental monitoring program, as applicable, following the parameters established (AbbVie policies, FDA, cGMP), reviews for reagents and standard preparations and their assays or suitability testing and/or media preparation and associated media checks.

+ Perform equipment routine monitoring of the laboratory instruments as scheduled,
performance logs reviews, PVT of Dissolution Bath, auxiliary logbook reviews, audit trail reviews, stability study pull reviews and metrology reviews.

+ Ensure that all testing is completed within established parameters and meet the quality attribute and regulatory compliance specifications.

Confirm and notify any OOT (Out of Trend) or out of control limits.

Participate in the laboratory assessment for out of trend or out of control limit.

+ Ensure Reference Standard characterization and requalification activities are performed per business need.

Such as TOC reagents, media preparation, USP Standards, AbbVie Reference Standard.

Maintain communication between customer and operation area to coordinate the dispensing and delivery of reference standard material based on customer’s procurement.

+ Have proficiency in laboratory analysis and understanding.

Be active in the process of solving issues related to the laboratory instruments and CDS system as applicable.

+ Provide constant support in the laboratory area.

Act as witness and provide independent verification to ensure the procedures are followed.

+ Perform the routine monitoring of the laboratory instruments and the PVT of the dissolution baths as schedule.

+ Confirm the reported results are valid and that documentation and calculation are accurate, complete, reliable, relevant, and contemporaneous.

Ensure consistency of the data reported.

+ Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement.

Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

+ Frequent to continuous computer usage (greater or equal to 50% of the workday) is required


Qualifications

Qualifications

+ High School or GED with at least six (6) years of relevant laboratory experience in similar industry; or Associate Degree in Science with a major in Biology, Microbiology or Chemistry preferred, and four (4) years of relevant laboratory experience; or Bachelors Degree in Science, with a major in Biology, Microbiology or Chemistry preferred, and two (2) years of relevant laboratory experience.

+ Four (4) years in Laboratory Technical Analysis and Data reporting such as basic knowledge of laboratory practices as an example of pH, Appearance, Electrophoresis, HPLC, ELISA, Bioburden, Endotoxin, Environmental Monitoring, HPLC, Dissolution, CDS System, LIMS, PVT of the dissolution baths among others preferred.

+ Two (2) years of experience in document control and data analysis preferred.

+ Related knowledge of Product Quality, Quality Control Lab Operations and Regulatory requirements preferred.

+ Advanced technical skills in technical lab operations and a general understanding of related business to properly assess the data generated preferred.

+ Good verbal and written communication skills, English, and Spanish.


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position.

Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range.

This range may be modified in the future.

​
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
+ This job is eligible to participate in our short-term incentive programs.

​
+ This job is eligible to participate in our long-term incentive programs​


Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.

The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law


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.



US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Required Skill Profession

Other General