Product Review Coordinator III, 2nd Shift
5 days ago
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 assignedQualifications
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 postingbased 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 orless 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 a 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 paidandmay be modified at the Companys sole and absolute discretion, consistent with applicable law. AbbVie 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.
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