Manufacturing Quality Assurance Specialist, 3rd shift

Overview

Abb Vie s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Job Description

The Manufacturing Quality Assurance Specialist is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, 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.

Supports the 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 MQA Section Manager and/or the Plant QA Manager. Purpose of role is ensure building is GMP ready.

• Responsible for implementing and maintaining the effectiveness of the Quality System within the manufacturing building. This individual will work a blend of desk on the production floor.
• Support the ensure that all quality goals are met, and all practices and procedures comply with company 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.
• Auditing of commissioning and validation documentation.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA s. Develops and implements statistical quality programs and process monitoring systems.
• For specific U.S. manufacturing sites, performs batch release.

• Bachelor s degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• GMP experience required; experience in Pharmaceutical Manufacturing preferred
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.
• Ability to be available during shift hours on Saturdays/Sundays

• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.
  
  Individual compensation paid within this range will depend on many factors including geographic location, andwemay ultimately pay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to…