Quality Engineer III

Allergan, Inc. Waco , TX 76701

Posted 1 week ago

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.

Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.

Position Overview

This position performs as QA specialist in the area of quality assurance oversight of operations, production, process and equipment systems and computer validation at the Waco facility. 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.

Main Areas of Responsibilities

  • Quality Assurance oversight of operational activities, production, and validations and Technical Services projects, ensuring that QA systems and manufacturing/engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.

  • Ensuring process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes.

  • Serving as the QA representative on validation and technical services projects.

  • Reviewing and approving as Quality Assurance site process and equipment validation documentation representative, including protocols, deviations, and final reports.

  • Generating appropriate purchasing (CE's) and documentation for Quality Assurance validations projects and URS and FRS requirements.

  • Supporting change control activities associated with processes and equipment validations.

  • Managing and coordinating QA support for new and existing process equipment validation implementations.

  • Serving as the QA liaison with all vested parties including QA/QC laboratories, IS, Manufacturing, and Engineering relating to process and equipment validations.

  • Providing CSV oversight based on the education and training of the individual.

  • Maintain a clean and organized work area.

  • Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.

  • Perform all assigned duties according to departmental SOP's and cGMP's.

  • Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.

  • Complete and remain current with all required cGMP and safety training.

  • Perform other duties as assigned.

  • 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.

Requirements

  • Demonstrated ability to apply analytical methods

  • Broad understanding of Quality Engineering activities

  • Detail-oriented and self-motivated

  • 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. for men and 35 lbs. for women.

Education and Experience:

  • Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution; Graduate degree is preferred.

  • Minimum of three (3) years of experience with a minimum of one (1) year working in relevant areas such as process validations or technology transfer.

  • A Master's degree may substitute for one year of experience.

  • Strong user of Excel and Statistical programs like Minitab

  • Prefer experience in a GMP regulated environment.

  • Prefer experience in an aseptic manufacturing environment

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Quality Control Technician III

Allergan, Inc.

Posted 1 week ago

VIEW JOBS 3/11/2019 12:00:00 AM 2019-06-09T00:00 Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team. Position Overview Ensuring that all inspections are conducted within the allowed release time as scheduled and that the areas are properly staffed. Incumbent will have the ability to perform all Incoming and Final QA inspections of products and components. This position is essential to the operation to Production/Manufacturing and Quality Assurance. Main Areas of Responsibilities: * Coordinates the daily activities of Incoming/Final Inspections by directing staff in sampling, inspecting, and releasing components and chemicals per pre-established procedures, verifying and approving all final QA inspections. * Verifying log book entries and performs required preventative maintenance relating equipment used in the area. * Responsible for handling all special requests originating from various Allergan, Inc., locations. * Responsible for coordinating the incoming "hot" list at a minimum of two times a week, ensuring that all personnel are prioritizing off the "hot" list. * Prepares and routes component deviations. * Demonstrates proficient knowledge of and performance in all functional areas of Incoming and Final QA. * Provides matrixes for inspection release time on a weekly basis. * Ensures and conducts the manual release of products in SAP when required. * Responsible for converting part numbers in SAP and updating SAP. * Responsible for conducting SOP revisions and verifications. * Reviews and revises procedures as needed or as directed by the supervisor. * Assists in the training of Incoming and Final QA employees to comply with all Allergan SOPs, cGMPs , and safety guidelines. * Provides input and assists in problem solving and analysis with continuous improvement. Preferred Skills/Qualification's * Ability to work effectively with peers and supervisors. * Good problem solving skills and be detailed oriented. * Detail oriented; thorough in thought process and following directions. * Good math skills; must be able to work and or calculate percentages. * Experience working in an Aseptic Production environment preferred. Requirements: * Able to lift up to 35 pounds (women), 40 pounds (men). * Must exhibit good written and verbal communication skills. * The ability to read, write and comprehend English and follow instructions in order to perform the responsibilities described above. * Ability to work under pressure and with general direction to meet deadlines, and concentrate on details and following instructions. * Three (3) to seven (7) years' experience in a Quality Assurance manufacturing environment. * Working knowledge of cGMPs with hands-on knowledge experience. * Thorough knowledge of SAP and AQL Inspectors rule. * Experience working in a GMP regulated environment preferred. Education and Experience: * High School education or GED equivalent. Allergan, Inc. Waco TX

Quality Engineer III

Allergan, Inc.