Senior Validation & Quality Systems Specialist

AbbVie Inc.; North Chicago (IL); Presencial; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare benefits

401(k) matching

Paid time off

Descripción de la vacante

AbbVie in North Chicago, IL seeks a Senior Support Specialist to plan and execute validation activities, manage SRM/ECC purchasing queues, and support QC Laboratory's validation program, ensuring timely delivery of goods and compliance with cGMP.

You will audit documentation, investigate deviations, draft SOPs, maintain the quality system, and collaborate with engineering resources on new installations and system validation while supporting CAPA processes.

Formación

• High school diploma or GED required; technical certification preferred.
• 6+ years in Manufacturing, Quality, or Engineering.
• Strong verbal and written communication, problem-solving ability.

Responsabilidades

• Participate in implementation and maintenance of the Quality System.
• Ensure compliance with company policies and regulations for Quality areas under responsibility.
• Execute tasks to implement the Validation Master Plan and maintain validated systems and processes.
• Maintain a change control program for validated/qualified systems.
• Ensure investigations of validation failures are thorough and documented in the CAPA system.
• Complete validation activities within allowed time and cost.
• Collaborate with plant/external engineering resources on new installations/systems to ensure documentation complies with cGMP and supports validation.
• Manage SRM shopping cart / ECC requisition queue to ensure timely processing of POs.
• Ensure carts, requisitions, and POs include required documentation and comply with purchasing policies.
• Participate in invoice resolution regarding changing POs.

Conocimientos

Verbal communication

Written communication

Analytical skills

Interpersonal skills

Negotiation skills

Educación

High School Diploma or GED

Technical school certification

Descripción del empleo

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Purpose:
The Senior Support Specialist plans and executes validation activities, processes shopping carts and requisitions in SRM/ECC to ensure timely delivery of the goods and services required to support the business. Under the direction of the Laboratory Operations Support Lead, this role supports implementation of the QC Laboratories’ validation program. Key responsibilities include auditing commissioning and validation documentation; leading and documenting investigations; implementing corrective and preventive actions; drafting and reviewing QC Laboratory standard operating procedures; reviewing and approving critical planned maintenance routines; preparing laboratory samples for qualification; supporting the establishment of plant quality systems; creating RCEs; and managing purchasing activities.

Responsibilities

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System.

• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.

• Executes tasks as assigned to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.

• Maintains a change control program for the validated/qualified systems to assure their capability of continuing to meet quality requirements.

• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.

• Ensure completion of validation activities within the allowed time and cost.

• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.

• Manage and process the SRM shopping cart / ECC requisition queue to ensure timely processing of POs.

• Ensure shopping carts, requisitions, and POs include the required documentation, correct category code, and are compliant with purchasing policies and procedures.

• Participate in invoice resolution regarding changing purchase orders as needed.

Qualifications

• High School/GED is required. Technical school completion/certification preferred.
• 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.
• 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 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.

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