Quality Analyst

DESCRIPTION:

Responsible for implementing an******** the effectiveness of theQuality System.
Support to ensure that all quality goals are met, an******** practicesan******** comply with AbbVie policies an******** regulations for theQuality areas under his /her responsibility.
Ensures investigations of plant events are complete******** an********accurately an******** include******** the plant CAPA system. Performsproduct impact analyses for plant events an******** product on QAhol******** appropriate.
Maintains an effective liaison an******** relationship with otherQuality areas an******** departments.
Participates on the Validation Review Boar******** the ManufacturingQuality Assurance function.
Approves standar******** procedures; ensures procedures comply withpolicy an******** sense.
Approves calibration requests an******** that these requests haveappropriate product / process limits assigned.
Demonstrates accountability an******** of EHS performance an********.
Audit API and/or finishe******** Product electronic an******** (paper)batch records to assure compliance with applicable GMPs, pol********procedures an********.
Document recommendations for deviations from approve******** an********to assure the capability of meeting product quality requirements priorto release.
Evaluate all deviations documente******** batch records an******** thenee******** a corrective action.
Provide for a constant review of the manufacturing process an********equipment an******** to assure compliance with proce********spec******** an********.
Give timely disposition to materials in the SAP system base********result of testing an******** with Regulatory Agency requirements.
Prepare certificate of analysis an******** of compliance for API.
Enter require******** information into the lot restriction managementsystem.
Assemble the batch recor******** package an******** per theapprove******** procedures.

QUALIFICATIONS:

Bachelor Degree in B******** B******** Chemistry or Engineering.
Minimum 3 years of experience in QA
Quality/compliance management skills - This position requires knowledgeof quality / compliance management as well as regulations an********affecting APIs an********.
Ability to work in a fast pace an******** changing environment -Subject to working with multiple interruptions an******** reasonablepressure due to the nature an******** of the area.
Goo******** an******** communication skills.
Goo******** solving an******** skills.
Goo******** relations / communications skills.