Barceloneta, PR, 00617, USA
1 day ago
QA Analyst (Temporary Position)
Company Description 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The QA Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on: policy &procedure, program management, patient record review, internal/external audit, and metrics and trend analysis and reporting. Responsibilities + Responsible for implementing and maintaining the effectiveness of the quality system + Conducts investigations and provides timely resolutions to variance, incident, exception issues. Participates in the development and implementation of permanent corrective actions. + Conduct internal audits on the business functions of Pharmacy Solutions and Supports external audit logistics and operations + Provides effective quality controls to the referral management, call center and fulfillment operations + 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, performance metrics and prepares daily/monthly reports of pharmacy solutions quality measurements + Manage QA lists, spreadsheets, and databases as required to support the business + Participates in Quality Improvement initiatives and assures customer satisfaction + Prepares ad hoc quality and other reports as requested by management and external customers + Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Oversees manufacturing operations to ensure practices are in alignment with approved procedures. + Performs product impact analyses for plant events and places product on QA hold where appropriate. + Participates on the Validation Review Board as the Manufacturing Quality Assurance function. + Approves standard operating procedures; change management and risk management documents. Significant work activities: + Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required + Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required + Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required Qualifications + Bachelor's Degree in Science (Chemistry, Biology, Microbiology, Industrial Chemistry) is required. + Minimum 2 years of experience in a quality position, within the aseptic area is required. + Previous experience managing documentation, change management, and performing manufacturing investigations is required. + Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint) + Excellent oral, written, and presentation skills in English and Spanish is required. + 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 The selected candidate must be available to work on a 1st and/ or 2nd shift, depending on business needs. Additional Information 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, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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