Support the Stability Program to assure studies are place in chambers and that samples are dispensed accurately and in a timely manner. Support the Reference Standard Program to ensure standards are stored, inventoried and dispensed in an accurate and timely manner. Ship samples domestically and international following requirements for shipping dangerous goods and/or controlled substances. Accurately, legibly and contemporaneously document these activities following current Good Manufacturing Practice guidelines and applicable procedures. Perform and verify visual inspections of reserve samples as part of complaint investigations, annual product reviews or other exception events. Maintain a neat and orderly work environment in a continuously audit ready.
•Dispense stability samples and reference standards from storage and deliver them to local testing laboratories or ship samples domestically and internationally, coordinating with Global Trade Compliance, the recipient and the shipping vendor to ensure all documentation such as invoices are completed correctly to prevent customs delays.
•Maintain inventory of stability materials, reserve samples and reference standards, placing them into their assigned environmentally controlled locations as well as purging these materials from inventory per retention schedules.
•Maintain environmentally controlled chambers, dispensing laboratories and own work space in a continuous orderly audit-ready state.
•Performance and/or verification of physical inspections of reserve samples in support of product complaints, investigations or annual reviews.
•Maintain accurate, legible, contemporaneous and thorough documentation of recordable stability, reserve sample and reference standard activities.
•Function as a Controlled Drug Analyst
• These responsibilities will sometimes require walking over one mile per day and will routinely require standing in place for prolonged periods of 2 hours or more per day. Lifting of heavy objects up to 50 lbs. will be required when occasionally handling large shipments of samples. In addition, handling of hazardous material will be required with proper used of personal protective equipment.
•Minimum of High school graduate; Bachelor's degree or Associate degree desired.
•2+ years of overall experience in Manufacturing, Quality or Engineering.
•Knowledge of GMP regulations and standards affecting pharmaceutical products.
•Must be able to achieve goals in a compliance regulated and performance driven environment.
•Some analytical or visual inspection experience with evidence of strong attention to detail.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.