AbbVie Senior Quality Analyst-Supplier Program in Barceloneta, Puerto Rico

Description:
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.
  • Coordinates resolution of problem relating to quality and performance of purchased materials with suppliers and ABL Manufacturing Quality Assurance.
  • Develops/consults new supplier candidates with the objective of enabling the supplier to meet minimum ABL quality requirements.
  • The incumbent monitors and manages implementation of new and existing processes that ultimately impact vendor product quality assurance.
  • Supports New Product development teams with recommendation on suppliers and design of incoming material and processes.
  • Performs supplier qualification of incoming material. These would include protocol development, design experiments, validation studies, etc.
  • Manage waivers for incoming material, implemented corrective actions and provides report.
  • Establish and document contact with suppliers concerning quality issues/concerns (i.e. nonconformity, deviation, defect report, waivers, etc.).

  • Perform assessment of supplier change notification (SCN) of incoming material. Monitor supplier change notification review through ABL Plant and AbbVie (as applicable) to ensure a timely completion.

  • Serve as the ABL Quality representative in relation to supplier qualification program and ensures supplier program comply with AbbVie requirements.

Qualifications:

Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering

Master's degree: not required but desired

Technical Skills:

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
Organization: Operations
Schedule: Full-time
Shift: Day
Travel: Yes, 5 % of the Time
Req ID: 1702933

Equal Opportunity Employer Minorities/Women/Veterans/Disabled