Senior Quality Risk Management Engineer

Purchaseyourfreedom; North Chicago (IL); On-site; USD 85,000 - 162,000; Full time

Job summary

AbbVie in North Chicago, IL is seeking a Senior Quality Engineer to lead Manufacturing Quality Assurance activities, resolve deviations, perform product impact analysis, and drive CAPA within a cGMP framework. You will coordinate QRM processes, support validation, commissioning, and change decisions, and ensure site practices meet regulatory requirements.

The role involves cross-functional collaboration with the QRM COE, exposure to FMEAs, risk assessments, mentoring on QRM, and documentation

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 6+ years of experience in Manufacturing, Quality or Engineering.
• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Responsibilities

• Serve as the site liaison between the Quality Risk Management Center of Excellence (QRM COE) and local stakeholders to support deployment of global QRM processes and communication of site feedback.
• Provide QRM SME oversight and guidance for risk management activities, such as FMEAs and other risk assessments specified in local and/or global procedures, by supporting cross-functional teams with methodology, procedural expectations, documentation quality, and risk-based rationale
• Provide QRM training and guidance as required, facilitate assignment of appropriate QRM training curricula to site personnel based on their risk-related responsibilities, and promote QRM best practices.
• Support Management Review activities by compiling and presenting required QRM metrics, site plans for upcoming FMEAs or other relevant risk assessments, significant residual risks, upcoming and past due mitigation actions.
• Monitor the site Quality Risk Management program to support adherence to global QRM procedures, risk outputs, and mitigation action status.
• Participate in global and local QRM documentation changes and change control activities by assessing site impact and providing QRM input as applicable.
• Participate in the Validation Review Board discussions as the QRM SME, providing risk-based input to support validation, commissioning, qualification, and change-related decisions.
• 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.
• Own and maintain applicable site-level Quality Risk Management documents and provide QRM expertise for the development, review, and facilitation of risk assessments used to support risk-based decisions, quality event investigations, and other site or product-specific risk evaluations.

Job description

• Compensation: USD 84,500 - USD 162,000 - yearly

Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Job Description

The Senior Quality Engineer 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.

Responsibilities

• Serve as the site liaison between the Quality Risk Management Center of Excellence (QRM COE) and local stakeholders to support deployment of global QRM processes and communication of site feedback.
• Provide QRM SME oversight and guidance for risk management activities, such as FMEAs and other risk assessments specified in local and/or global procedures, by supporting cross-functional teams with methodology, procedural expectations, documentation quality, and risk-based rationale
• Provide QRM training and guidance as required, facilitate assignment of appropriate QRM training curricula to site personnel based on their risk-related responsibilities, and promote QRM best practices.
• Support Management Review activities by compiling and presenting required QRM metrics, site plans for upcoming FMEAs or other relevant risk assessments, significant residual risks, upcoming and past due mitigation actions.
• Monitor the site Quality Risk Management program to support adherence to global QRM procedures, risk outputs, and mitigation action status.
• Participate in global and local QRM documentation changes and change control activities by assessing site impact and providing QRM input as applicable.
• Participate in the Validation Review Board discussions as the QRM SME, providing risk-based input to support validation, commissioning, qualification, and change-related decisions.
• 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.
• Own and maintain applicable site-level Quality Risk Management documents and provide QRM expertise for the development, review, and facilitation of risk assessments used to support risk-based decisions, quality event investigations, and other site or product-specific risk evaluations.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Additional Information

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 Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.