Laboratory Data Auditor (2nd Shift)

Allergan; Barceloneta (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

AbbVie in the United States/Puerto Rico region is seeking a Laboratory Analyst to ensure analytical and microbial testing aligns with test method objectives and regulatory expectations. You will perform tests on raw materials, finished products, and environmental samples, reviewing procedures to guarantee data integrity and regulatory compliance.

Responsibilities include instrument maintenance, data verification, OOT/out-of-control investigations, reference standard management, and collaboration

Qualifications

• High school or GED with 6+ years in a lab setting.
• Associate or Bachelor's degree in science with relevant lab experience.
• Experience with pH, electrophoresis, HPLC, ELISA and environmental monitoring.
• Knowledge of regulatory requirements and quality control principles.
• Strong written and verbal English; Spanish helpful.

Responsibilities

• Perform analytical and microbial tests per required methods and documentation.
• Monitor and maintain laboratory instruments; review performance logs.
• Identify out of trend/out of control results and participate in investigations.
• Manage reference standards and coordinate material dispensing with operations.
• Provide support to EHS and drive continuous improvement.

Skills

English proficiency

Spanish proficiency

Verbal communication

Written communication

Education

High school or GED

Associate degree in science

Bachelor's degree in science

Tools

HPLC

ELISA

Bioburden

Endotoxin

Environmental Monitoring

CDS System

LIMS

PVT of dissolution baths

Job description

Company Description

About AbbVie

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

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:

• 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.
• Generates and manages non-hazardous and hazardous waste, according with the internal operating procedures and in compliance with local and federal regulations.

Qualifications

Qualifications:

• High School or GED with at least six (6) years of relevant laboratory experience in similar industry.
• Associate Degree in Science with a major in Biology, Microbiology or Chemistry, preferred, and four (4) years of relevant laboratory experience.
• 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.
• Availability: Tuesday to Saturday shift.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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