Specialist, Quality Assurance

AbbVie

  • Barceloneta, PR
  • Permanente
  • Tiempo completo
  • Hace 1 hora
Company DescriptionAbbVie'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 . Follow @abbvie on , , , , and .Job DescriptionPurposeThe Specialist, Quality Assurance is responsible for QA batch record review and disposition assuring that bulk and finished products batch record documentation complies with Abbvie policies, regulatory requirements and current Good Manufacturing Practices. The function ensures the plant products meet specifications and quality requirements. This will require interaction with other Quality Assurance, Production, Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records, investigation of deviations, exceptions and nonconformance reports.ResponsibilitiesList up to 10 main responsibilities for the job. Include information about the accountability and scope.
  • Audit API, Bulk and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
  • Evaluate potential discrepancies detected in batch records and determine the need for a corrective action. Approve MES exceptions related to production support.
  • Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.
  • Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. Prepare Certificate of Analysis, Certificates of Compliance for API and/or finished Drug Product.
  • Enter and verify batch information into the lot restriction management system. Assemble the batch record review package and label per the approved retention procedures.
  • Support the annual product quality review process.
  • Prepare reports related to Right the First Time, Release Cycle Time, Regulatory Audit requests and Product Quality Review. Revise procedures as required.
  • Coordinate and participate in plant weekly meetings for Shop Floor Control to discuss batch record status including discrepancies and/or issues that may impact batch release.
  • Demonstrates accountability and responsibility of EHS performance and compliance.
  • Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. 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.
  • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
  • Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
QualificationsQualifications
  • Bachelor's Degree in Science preferably in Biology, Chemistry, Biotechnology, Engineering or other related fields.
  • 2 years of experience in Quality regulations and standards affecting pharmaceutical, chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)
  • Knowledge and experience in manufacturing of pharmaceutical or biotechnology products is needed.
  • At least 1 year of experience working in highly computerized Operations environments. Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is necessary.
  • Incumbent must have excellent problem solving, analytical and communication and interpersonal skills. Excellent oral and written communication skills in English and Spanish are required.
  • For biologics, experience in aseptic processing is preferred.
Additional InformationApplicable 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 ofthis 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. ​This job is eligible to participate in our long-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 anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand 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.US & Puerto Rico only - to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

AbbVie