AbbVie Senior Quality Analyst in Barceloneta, Puerto Rico
During routine operations, the Sr. Quality Analyst is responsible for carrying out Manufacturing Quality Assurance functions within the AbbVie Biotechnology, LTD (ABL) plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, leading the SVP Media Fill Program, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant. In addition, support the SVP manufacturing operations in regards to line inspections, quality visual inspections, customer complaints, QA oversight and disposition of the drug product filled units for further processing.
The Sr. Quality Analyst may support the ABL Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly-identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the SVP QA Operations Manager, and/or the Plant QA Manager. Responsible for implementing and maintaining the effectiveness of the SVP Quality System. Ensure that all quality goals are met, and all practices and procedures comply with GPO and Corporate 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.
Performs SVP line inspection prior to start operations and quality visual inspections as per approved procedures as required
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
Highly developed verbal and written communication skills in both Spanish and English. Highly developed problem solving and analytical skills Highly developed interpersonal relations / communications skills Highly developed negotiation skills This position requires a professional with a broad spectrum of quality/compliance management skills preferable in parenteral manufacturing by aseptic processing. This position also requires knowledge of regulations and standards affecting APIs, Biologics and Drug Product
Position Titles or Description of Expertise Expertise in Quality Assurance, or Manufacturing, or Validation- 2 years Experience in Health care industry- 2 years Total combined minimum years of experience required- 6 years total (/Not necessarily the sum of the above) /
Job Classification: Experienced
Job: QUALITY ASSURANCE
Primary Location: USA-Puerto Rico-Barceloneta
Travel: Yes, 5 % of the Time
Req ID: 1702933
Equal Opportunity Employer Minorities/Women/Veterans/Disabled