Svp - Quality Analyst (3Erd Shift)

- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Support to ensure 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.
- 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 and places product on QA hold where appropriate.
- Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
- Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approves standard operating procedures; ensures procedures comply with policy and make sense.
- Approves calibration requests and ensures that these requests have appropriate product /process limits assigned.
- Demonstrates accountability and responsibility of EHS performance and compliance.

- Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering.
- Master's degree: not required but desired.

Technical Skills:

- Good verbal and written communication skills in both Spanish and English.
- Good problem solving and analytical skills.
- Good interpersonal relations / communications skills.

Experience Required:

- Quality/compliance management skills. This position requires knowledge of quality / compliance management as well as regulations and standards affecting APIs and Biologics.
- Position Titles or Description of Expertise Years
- Experience in Health care industry – 2 years.
- Total combined minimum years of experience required – 2 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.
- Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.

Additional Information

- Significant Work Activities and Conditions: Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Travel: No
- Job Type: Experienced
- Schedule: Full-time
- Job Level Code: IC