AbbVie - Municipio de Jayuya, PR

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ANALYST QA - 120000038T Description
      AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 28,000 people worldwide and markets medicines in more than 170 countries.

      During routine operations, the Quality Analyst is responsible for carrying out plant investigations (nonconformities and potential nonconformities) and preparing required deviations including resolution of deviations, performance of product, impact analysis and corrective and preventive action for events. The incumbent will lead and write investigations, assist in quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.

      The Quality Analyst is responsible for the execution of multiple functions that set the pace and influence the depth of inspections made by regulatory agencies. These are:
      CAPA / IRB (Investigation Review Board) Team member: define corrective and preventive actions according to the nature and complexity of the quality event under investigation.
      Customer Complaint Team member: Support in writing complaint investigations and in the identification of root cause of complaint failures in a timely manner to ensure appropriate actions are taken to protect customer’s health.
      Improvement projects aimed to enhance the product and/or processes at the site.

      Major responsibilities:

      *Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events.
      *Ensures the degree to which a quality problem or nonconforming product is investigated is in alignment with the significance and risk and that root cause is timely determined.
      *Analyze data from these sources to identify existing product and quality problems that may require corrective actions.
      *Consolidate multiple reports or investigations into trend investigations.
      *Be the Exception report/investigation system expert and be able to produce required reports from within the system for audits or by management request.
      *Follow-ups on pending CAPAS.
      *Maintains an effective liaison and cooperative relationship with other quality areas, plant departments and with divisional QA representatives.
      *Participates on the Investigation Review Board as the Quality Assurance function.
      *Demonstrates accountability and responsibility of EHS performance and compliance.
      Participate of product and/or process improvement projects

      Incumbent must have a creative, versatile and analytical mind to resolve quality related issues, to promote and maintain a high level of quality in the Jayuya plant. Should also have a high degree of initiative, decision making, technical knowledge and responsibility that would enable incumbent to perform efficiently with minimum direction. This person should influence and obtain commitments on corrective actions completion from all employee levels at the Jayuya plant.

      Bachelor’s degree in science preferable Biology, Chemistry or Engineering

      Technical skills:
      Good verbal and written communication skills in both Spanish and English
      Good problem solving and analytical skills
      Good interpersonal relations and negotiation skills

      Education Requirements: Bachelor’s degree in science preferable Biology, Chemistry or Engineering

      Significant Work Activities and Conditions Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
      Job Classification : Experienced
      Primary Location : USA-Puerto Rico-Jayuya

      Organization : GPO-Pharma Ops
      Schedule : Full-time
      Shift : Day
      Travel : Yes, 20 % of the Time

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