
Quality Engineer
BioSpace • North Chicago, Illinois, United States
Role & seniority: Manufacturing Quality Assurance Specialist (Supplier QA) focusing on site supplier quality and QA support.
Stack/tools: Quality System governance; supplier qualification/maintenance; CAPA and product impact analyses; change management; SOP approvals; validation collaboration; calibration requests; statistical quality programs.
Top 3 responsibilities
-
Manage approved supplier list (qualification, performance, maintenance) and support supplier-related QA activities.
-
Maintain and implement the Quality System; assist with regulatory audits; investigate plant events and manage product/material holds.
-
Support validation of new process equipment, review certified systems, participate in the Validation Review Board, and approve SOPs and calibration requests.
Must-have skills
-
Bachelor’s degree in Biology, Chemistry, Engineering, or related field; 2+ years in Manufacturing, Quality, or Engineering.
-
Strong verbal/written communication; problem-solving and analytical abilities.
-
Interpersonal, negotiation skills; knowledge of quality/compliance management and regulatory standards for API/Bulk Drug/Finished goods.
Nice-to-haves
-
Experience with regulatory audits, CAPA systems, and calibration management.
-
Exposure to validation activities and development of statistical quality programs.
Location & work type: United States (including Puerto Rico); on-site; full-time (pay/disclosure as applicable).
Full Description
Company Description
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.
Responsibilities
Job Description
In this role, an individual supports site manufacturing operations and quality by managing the approved supplier list including supplier qualification, performance, and maintenance. They help maintain and implement the company's Quality System, ensuring all activities and procedures align with company standards and regulatory requirements. The person also assists Incoming and Manufacturing QA in investigating plant events, performing product impact analyses, and managing product/material holds when needed.
They collaborate effectively with other local and global QA and Technical departments, participate as the Supplier QA in Global Supplier Center of Excellence (CoE) meetings, and approve standard operating procedures and change management actions to ensure regulatory and procedural compliance. This individual will support site compliance and regulatory audits as the subject matter expert for local supplier QA.
Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements. Responsible for implementing and maintaining the effectiveness of the Quality System. Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations. 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. Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.
Qualifications
Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience 2+ 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 Good negotiation 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 the timeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemay ultimatelypay 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/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Companys 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.
US & Puerto Rico only - to learn more, visithttps: //www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more
https: //www.abbvie.com/join-us/reasonable-accommodations.html