Analyst, QA
About the Company
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.
About the Role
The QA Analyst supports the Quality Manager in the execution and oversight of the Quality System, with primary responsibility of batch record review, batch release documentation, and product shipment authorization. This includes support for policy and procedures, program management, internal and external audits, and metrics, trend analysis, and reporting.
Responsibilities
- Responsible for implementing and maintaining the effectiveness of the quality system
- Reviews batch release documentation and batch records to support product disposition and shipment authorization
- Tracks, trends, and reports on batch record and product release activities
- Release batch records in electronic systems according to global, local, customer, and regulatory requirements. Ensure all in-process and release testing is complete and all quality holds can be removed for release
- Ensure batch records are retained and filed securely based on applicable document retention procedures
- Owns and drives updates to AbbVie Product specification documents
- Provides effective quality controls for commercial products, including solid dosage forms, select liquids, and vials, as well as third-party manufactured products
- Monitors compliance with all AbbVie and Pharmacy Solutions policies and procedures, in addition to all federal, state, local governmental, and pharmacy laws and regulations
- Develops QA training programs and materials and provides training to departmental personnel
- Evaluates, analyzes, and trends quality indicators, data, and performance metrics, and prepares daily and monthly reports of Pharmacy Solutions quality measurements
- Manages QA lists, spreadsheets, and databases as required to support the business
- Participates in Quality Improvement initiatives and assures customer satisfaction
- Conducts investigations and provides timely resolutions to variance, incident, and exception issues; participates in the development and implementation of permanent corrective actions
- Prepares ad hoc quality and other reports as requested by management and external customers
- Conducts internal audits on business functions of Pharmacy Solutions and supports external audit logistics and operations
Qualifications
- BS in a scientific discipline or related experience
- Minimum of 2 years experience in a Quality related field
- Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)
- Good oral, written, and presentation skills
- Sound decision making and problem solving skills to assure business unit compliance
- Strong analytical skills, ability to analyze data and trends and draw conclusions
- Good mathematics background with an understanding of basic statistical concepts
Preferred Qualifications
- Experience with batch record release and documentation
Benefits
- Paid time off (vacation, holidays, sick)
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Eligibility to participate in short-term incentive programs
Pay
The compensation range described is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation paid within this range will depend on many factors including geographic location, and may ultimately differ from the posted range. This range may be modified in the future.