Allergan Senior Quality Laboratories Analyst in Cincinnati, Ohio
Senior Quality Laboratories Analyst
Cincinnati, Ohio, United States at https://agn.referrals.selectminds.com/jobs/7013/other-jobs-matching/location-only
Jan 03, 2019Post Date
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.
A Sr. Quality Laboratories Analyst is an advanced laboratory position. This individual is largely responsible for contributing to and managing laboratory support operations such as stability program management, equipment qualification and calibration program management and analytical data review. Provide department with analytical services including method validation, verification, transfer and remediation. A Sr. Quality Laboratories Analyst facilitates projects related to laboratory compliance initiatives for alignment with current industry standards
Main Areas of Responsibilities:
Demonstrate sound knowledge of cGMP requirements and practices including extensive knowledge of the USP/EP/JP, ICH and FDA Guidance Documents relating to pharmaceutical Quality Laboratories.
Identify deficient areas, develop and manage solutions through implementation to ensure departmental compliance with agency requirements.
Develop implementation strategies for new regulations.
Manage the Quality Control Stability Program including but not limited to creation and approval of stability protocols, initiating stability studies and performing stability pulls.
Utilization of statistical tools for data trend analysis and identification of out of trend results.
Publish annual stability reports for inclusion in regulatory documentation.
Perform validation of analytical methods for raw materials, in-process and finished products.
Perform verification of compendia methods.
Support the technological transfer of analytical methods to and from PR&D or other Allergan sites.
Perform development, execution and evaluation of scientific studies to remediate the performance of current analytical methods.
Qualification of laboratory equipment; includes developing, writing and executing URS/IQ/OQ/PQ protocols and ensuring cGMP and CFR 21 part 11 compliance.
Identify and implement new analytical technologies and software solutions to improve laboratory effectiveness, efficiency and compliance.
Possess the skills and experience to thoroughly review analytical data against industry standards and local procedures.
Deliver feedback with diplomacy and in a manner which promotes learning and development.
Provide leadership as a Subject Matter Expert (SME) in Chemical Analysis or QC Compliance systems.
Demonstrate competency in the operation of common analytical instrumentation (e.g. UPLC, HPLC, Dissolution, GC, FTIR, UV/Vis) and other USP instrumental and wet chemistry techniques used in a pharmaceutical Quality Control Laboratory.
Demonstrate the ability to learn new techniques and technologies in an independent, efficient and effective manner.Demonstrate the ability to learn and master software programs utilized in the Quality Laboratory (i.e Empower, LIMS, SmartLab).
Deliver departmental training and mentorship to junior staff members to ensure laboratory is adequately trained on compliance topics, analytical instrument and safety.
Develop and calculate metrics to measure success against department and corporate goals and identify opportunities for improvement.
Demonstrate excellent technical writing skills. These skills should include the ability to independently write and review documents that ensure cGMP compliance e.g. analytical test methods, method validation protocols and reports, instrumentation qualification documentation (URS/IQ/OQ/PQ), laboratory investigations, Standard Operating Procedures, and Change Controls.
Demonstrate excellent oral communication skills: Oral communication skills should include a demonstrated ability to effectively articulate complex scientific information in a concise and logical manner. Present information to small groups of internal and external scientist in meetings.
Demonstrate attention to detail and keep accurate records.
Demonstrates the ability to work independently and make sound decisions on projects to determine new or improved processes and procedures. Often acts as a facilitator and team leader.
Perform and lead the evaluation, development and execution of complex scientific studies requiring independent action and high degree of initiative to resolve issues.
Represent Quality Control in multi-disciplinary teams and working groups.
Serve as back-up for laboratory Manager.
Education and Experience
Bachelor’s degree in Chemistry or related scientific field.
More than 10 years experience in a GMP laboratory environment.
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.