Senior Quality Analyst - Supplier Program USA, Puerto Rico, Barceloneta New 1 additional location USA, Puerto Rico Quality Assurance Requisition 1904091 The incumbent is responsible to comply with AbbVie Quality and Regulatory (AQR) Policies and procedures, AbbVie Biotechnology Plant (ABL) procedures, and Food and Drug Administration (FDA), cGMP, and other international regulations and requirements, as applicable. Responsible for implementing and maintaining effectiveness of the Quality Systems. Coordinates resolution of problem relating to quality and performance of purchased materials with suppliers and ABL Manufacturing Quality Assurance. Develops/consults new supplier candidates with the objective of enabling the supplier to meet minimum ABL quality requirements. The incumbent monitors and manages implementation of new and existing processes that ultimately impact vendor product quality assurance. Supports New Product development teams with recommendation on suppliers and design of incoming material and processes. Performs supplier qualification of incoming material. These would include protocol development, design experiments, validation studies, etc. Manage waivers for incoming material, implemented corrective actions and provides report. Establish and document contact with suppliers concerning quality issues/concerns (i.e.nonconformity, deviation, defect report, waivers, etc.). Perform assessment of supplier change notification (SCN) of incoming material. Monitor supplier change notification review through ABL Plant and AbbVie (as applicable) to ensure a timely completion. Serve as the ABL Quality representative in relation to supplier qualification program and ensures supplier program comply with AbbVie requirements. Evaluates AbbVie Specification Acceptance Letter exception and assess need for elevation to ABL GCC QA/IQA/SQA Section Manager, as needed. Updates and maintains the System Application Product (SAP) system with current specification date, approval of supplier sites and/or purchasing control Reviews and maintains the Approved Supplier List. Interfaces with and maintains cooperative relationships with plant and AbbVie departments to assure the total integrity and usability of incoming materials. Serves as an effective liaison and maintains a cooperative relationship with other Quality areas, Plant departments, AbbVie North Chicago, AbbVie Bioresearch Center counterparts, and TPMs as needed. Active participation in Management Review presentations. Assists section with the follow-up and close out of the management reviews action items upon their implementation. May act as backup resource, when the GCC QA/IQA/SQA Section Manager is not present. During these periods, he/she is authorized to make decisions in quality system matters in accordance with an independent judgment with guidance and support from the ABL Quality Manager and or the ABL Plant Manager. Ensures that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his/her responsibility. The functions of the ABL Senior Quality Analyst encompass a broad spectrum of projectassignments. These would typically include: Vendor development: The incumbent will assess current abilities of a chosen vendor and design and implement a plan with the vendor to improve/eliminate recognized deficiencies. Knowledge/ Education Required: Bachelor's degree in Natural Sciences, Biology, Chemistry or Engineering. Master's degree: not required but desirable Technical Skills: Highly developed verbal and written communication skills in English Highly developed verbal and written communication skills in Spanish Highly developed problem solving and analytical skills Highly developed interpersonal relations/communications skills Highly developed negotiation skills Highly developed analytical skills Experience Required: Quality related work in the pharmaceutical or medical device Health Care Organization. 6 years Total combined minimum years of experience required. 6 years (Not necessarily the sum of the above) Quality, Safety & Environmental Responsibilities: Fast paced and continuously changing environment. Subject to working with multiple interruptions and under reasonable pressure due to the nature and function of the area. Additional Information AbbVie is an Equal Employment Opportunity employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic. Significant Work Activities and Conditions: N/A Travel: Yes, 10 % of the Time Job Type: Experienced Schedule: Full-time
