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.