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
- 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 problems 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
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable 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.
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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
