Advertising/Marketing/Public Relations, Biotechnology and Pharmaceutical, Engineering, Finance/Economics, Information Technology, Sales, Science, Quality Control
Job Description
Documentation Coordinator II
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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
The Batch Record Reviewer audits manufacturing and packaging batch records for accuracy and compliance to AbbVie policies and procedures and performs transactions in inventory systems to release the batch for further processing.
Responsibilities
Review and audit the data and records generated by Manufacturing and Packaging Operations in the processing of a material or product batch
Ensure any batch record errors are corrected, all batch record components are present, and exception documents are referenced and approved
Ensure all in-process and release testing is complete and all Quality holds are released
Interface with various electronic databases/systems to interpret data pertinent for release to specific countries
Ensure batch records are retained and filed securely
Ensure Quality goals are met and all practices and procedures comply with Company policies and applicable regulations
Interact with other AbbVie departments, external customers, and regulatory agencies
May release batch records in electronic systems according to global, local, customer, and regulatory requirements
Qualifications
Minimum High School graduate; Bachelor's or Associate's degree desired
2+ years of overall experience in Manufacturing, Quality or Engineering
Minimum 5 years of experience in a manufacturing/finishing environment is desired
Knowledge of GMP regulations and standards affecting pharmaceutical products
Good analytical skills and attention to detail
Good interpersonal relations / communications skills
Good verbal and written communication skills
Must be available to work daily overtime, including weekends, as needed
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 Companys 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.
