Product Review Coordinator III, B2 Shift

3 weeks ago

Waco, Texas, United States AbbVie Full time

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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

Job Summary

This position will be responsible for reviewing finished product, semi-finished product, and compounding Batch Records for all products manufactured and/or packaged at the Waco facility ensuring compliance with Standard Operation Procedures and current Good Manufacturing Practices. This position is responsible for performing the Quality Assurance review of product records to support the final disposition process in Waco and coordinating training within the department. Responsible for the issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments at the Waco facility with compliance to site Standard Operating Procedures and current Good Manufacturing Practices.

Job Details

This position is responsible for the following:

Real time Review and approval of records by QA on the shop floor. These records include but not limited to finished product, semi-finished product, and compounding Batch Records.Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.Make decisions consistent with job responsibilities, regulations, procedures and policies. Provide appropriate comments to cGMPs documents, when needed. Provide timely feedback and details to supervision and other impacted personnel.Work together with Operations on resolving quality events on time.Provide approval for re-work and in-process retest forms as well as any other supporting document that requires Quality signature.As part of the batch review process perform continuous Gemba walks in the operation area.Complete and conform to all training requirements for job role, including company-required and job role-specific training.Carry out and assist in the on-going training of new and existing personnel, as appropriate.Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job.Empowered to make Quality decisions.Be part of Operation area T-2 meetings.Participate and support OPEX initiatives and seek process innovation and continuous process improvement.Reviews documents and collaborates with Production to identify defects and manufacturing trends.Actively provides input and suggestions to help analyze and resolve Production problems.Prepares required documentation regarding batch disposition to international sites as required.Identifies and brings to resolution all batch record discrepancies to prevent a regulatory impact.Performing the Quality Assurance Issuance of all batch related documents for manufacturing, production, validation, and quality assurance departments.Issue batch records to support manufacturing and Production for the Waco facility ensuring accuracy, compliance, adherence to Data Integrity, and current Good Manufacturing Practices.Issue PSO, Clinical Studies, Demonstration, and Validation Batch Records for Production use.Assist Documentation Department to prepare, assign, and issue logbooks for the Waco facility.Perform other duties as assigned
Qualifications
Education and Experience:

Minimum requirements for this position are:

Education

High School Diploma or GED Equivalent. Associates Degree preferred or bachelors degree in the Sciences or Technical field preferred.

Experience: Technical

Three (3) years of experience in handling and reviewing documentation records.

Experience: Systems

One (1) year of both Microsoft Word and Microsoft Excel experience. SAP experience preferred.

Experience: Regulatory

Three (3) years of experience in a CGMP Environment

Experience: Aseptic

Prefer experience in an aseptic manufacturing environment

Essential Knowledge, Skills & Abilities:

Excellent analytical and problem-solving skills, detail oriented.Excellent organizational skills. Ability to manage multiple tasks.Working knowledge of Quality Assurance systems, cGMPs, ISO 13485, CMDRs, and EMEA regulations.Detail-oriented and self-motivatedExcellent hand-eye coordination and manual dexterity.Excellent math skills; ability to add, subtract, multiply, and divide.Ability to read, comprehend, write, and communicate effectively in English.Ability to carry out detailed written or oral instructions.Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.Physically able to lift up to 40 lbs.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local 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 time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status. US & Puerto Rico only - to learn more, visit

  • Quality Assurance Product Review Specialist III

    2 weeks ago

    Waco, Texas, United States AbbVie Full time

    Job OverviewAt AbbVie, we are dedicated to discovering and delivering innovative solutions that address significant health challenges. Our focus spans various therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as our Allergan Aesthetics portfolio. For more information about our mission, please visit our website.Position...

  • Senior Product Quality Reviewer

    1 week ago

    Waco, Texas, United States AbbVie Full time

    Job OverviewAt AbbVie, we are dedicated to discovering and delivering innovative therapies that address significant health challenges. Our commitment spans various therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as our offerings in Allergan Aesthetics. For further details about our mission, please visit our...

  • Quality Assurance Product Review Specialist III

    2 weeks ago

    Waco, Texas, United States AbbVie Full time

    Job OverviewCompany Overview:AbbVie is dedicated to the discovery and delivery of groundbreaking medications and solutions that tackle significant health challenges today while preparing for the medical needs of tomorrow. Our goal is to make a substantial difference in the lives of individuals across various critical therapeutic domains, including...

  • Warehouse Associate

    1 week ago

    Waco, Texas, United States Adecco Full time

    Job SummaryAdecco is seeking a skilled Warehouse Associate to join our team in a fast-paced production facility. As a key member of our operations team, you will be responsible for ensuring the efficient packaging and shipping of products.Key ResponsibilitiesPackage cartons into shippers and palletize completed shippersMonitor product quality and ensure...

  • Equipment Technician IV, MD Packaging, B2 Shift

    3 months ago

    Waco, Texas, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Warehouse Associate

    1 week ago

    Waco, Texas, United States Adecco Full time

    Job SummaryAdecco is seeking a skilled Warehouse Associate to join our team in a fast-paced production facility. As a key member of our operations team, you will be responsible for ensuring the efficient packaging and shipping of products.Key ResponsibilitiesPackage cartons into shippers and palletize completed shippersMonitor product quality and ensure...

  • Warehouse Associate

    3 days ago

    Waco, Texas, United States Adecco Full time

    Job SummaryAdecco is seeking a skilled Warehouse Worker to join our team in a fast-paced production facility. As a Warehouse Worker, you will be responsible for packaging cartons into shippers, palletizing completed shippers, and monitoring product quality.Key ResponsibilitiesPackage cartons into shippers and palletize completed shippersMonitor product...

  • Manufacturing Technician II, Compounding, B2 Shift

    1 month ago

    Waco, Texas, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Psychologist III

    5 days ago

    Waco, Texas, United States Texas Department of Aging & Disability Services Full time

    Job Summary:The Texas Department of Aging & Disability Services is seeking a highly skilled Clinical Psychologist to join our team in providing exceptional care to children and adolescents. As a Psychologist III, you will be responsible for providing professional supervision and consultation to psychology staff, evaluating psychological and behavioral...

  • Analytical Lab Technician I-III

    2 weeks ago

    Waco, Texas, United States Planet Pharma Full time

    Position: Laboratory TechnicianCompany: Planet PharmaContract Duration: 6-month assignmentRequired Education: Bachelor's degree with a minimum of 3 years' experience in HPLCPreferred Experience: Familiarity with pharmaceutical or biotechnology quality control testingShift Availability: Based on candidate qualifications2nd Shift: Monday to Friday, 2 PM - 10...

  • Advanced Materials Technician III

    2 weeks ago

    Waco, Texas, United States Howmet Corporation Full time

    Position Overview:Howmet Fastening Systems is seeking a Materials Technician III for our Blind Products Department. This role involves executing advanced materials tasks that ensure the seamless flow of materials throughout our manufacturing operations. The successful candidate will possess a comprehensive understanding of enterprise systems relevant to this...

  • Custodian III

    5 days ago

    Waco, Texas, United States Texas Department of Aging & Disability Services Full time

    Job SummaryThe Texas Department of Aging & Disability Services is seeking a highly skilled and experienced Custodian III to join our team. As a key member of our facilities maintenance team, you will be responsible for ensuring the cleanliness and safety of our state hospital buildings and treatment units.Key ResponsibilitiesPerform highly complex custodial...

  • Child and Adolescent Psychologist

    1 week ago

    Waco, Texas, United States Texas Department of Aging & Disability Services Full time

    Job Overview: Are you passionate about fostering personal and professional growth while making a meaningful difference in the lives of children and adolescents? Do you value collaboration, reliability, and inclusivity in a workplace? The Texas Department of Aging & Disability Services is committed to cultivating a diverse community where employees feel...

  • Facilities Maintenance Coordinator

    5 days ago

    Waco, Texas, United States Texas Department of Aging & Disability Services Full time

    Job Description:We are seeking a highly skilled and experienced Custodian III to join our team at the Texas Department of Aging & Disability Services. As a key member of our facilities maintenance team, you will be responsible for ensuring the cleanliness and safety of our state hospital buildings and treatment units.Key Responsibilities:Perform highly...

  • Supply Chain Coordinator

    1 week ago

    Waco, Texas, United States Alcom of Texas Full time

    Job OverviewPOSITION: Logistics CoordinatorSTATUS: Non-exemptREPORTS TO: Logistics ManagerDIRECT REPORTS: NonePOSITION SUMMARY:This role is essential for managing the documentation necessary for the transportation of trailers, both within the country and internationally. The Logistics Coordinator ensures that all paperwork is completed with precision and...

  • Supply Chain Coordinator

    2 weeks ago

    Waco, Texas, United States Alcom of Texas Full time

    Job OverviewPOSITION: Logistics CoordinatorSTATUS: Non-exemptREPORTS TO: Logistics ManagerDIRECT REPORTS: NonePOSITION SUMMARY:This role is integral to managing the documentation necessary for the shipment of trailers, both domestically and internationally. The Logistics Coordinator ensures that all paperwork is accurately completed in compliance with...

  • Manufacturing Technician I, MD Fill, 2nd Shift

    1 month ago

    Waco, Texas, United States AbbVie Full time

    Company DescriptionAbbVie'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...

  • Logistics Warehouse Coordinator

    1 week ago

    Waco, Texas, United States Select Source International Full time

    Job OverviewWe are seeking a dedicated Logistics Warehouse Coordinator to join our team. This role is essential in ensuring the efficient management of materials within our warehouse operations.LocationWaco, TX, USAKey ResponsibilitiesReceive, verify, and categorize incoming raw materials and shipping components.Create and print labels in accordance with our...

  • Project Coordination Specialist

    2 weeks ago

    Waco, Texas, United States Brazos River Authority Full time

    Job OverviewPosition Title: Project ManagerPay Grade: 615Work Environment: Central OfficeRole Summary:The primary objective of this role is to deliver comprehensive project management assistance for the Brazos River Authority (BRA). This includes engaging in BRA's strategic capital planning and management efforts, executing project management...

  • Manufacturing Production Associate

    2 weeks ago

    Waco, Texas, United States Sedona Staffing TX Full time

    Welcome to Sedona StaffingWe are currently in search of dedicated Production Workers for a manufacturing facility in the Waco area. If you are pursuing a career in production, this opportunity may be ideal for you.Available Shifts:1st Shift: 5 AM to 4 PM or 7 AM to 3:30 PM2nd Shift: 3 PM to 1 AM3rd Shift: 11 PM to 7 AMCompensation Rates:1st Shift: $13.00/hr...