Job Details

Senior Quality Control Analyst

Company name
Allergan, Inc

Location
Irvine, CA

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Job Description
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 pharmaceuticals and biologic products for patients around the world.\r\r \rAllergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular 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.\r\r \rOur success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right. \r\r \r\rJoin one of the world’s fastest growing pharmaceutical companies! \r\r \r\rAt Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.\r\r \r\rPosition Description\r\r \r\rThe Quality Control (QC) Sr. Analyst will primarily provide analytical support for the manufacture, release, and stability testing of GMP drug substance produced at Allergan DSO.  Contributes to the completion of specific programs and projects.  Failure to obtain results, or erroneous decisions, would result in major program delays and considerable expenditure of resources.\r \rMain Areas of Responsibilities\r\r\rProvide analytical support for the manufacture, release, and stability testing of drug substance produced at DSO \r\r\rHighly proficient at GMP documentation, principles and requirements.\r\r\rRegulatory compliance and validation activities\r\r\rGMP systems support including software support and SOP maintenance \r\r\rContinuous improvement\r\r\rUnderstanding of the technical principles, theories, concepts and best practices of the analytical techniques used in the chemical analysis of drug substances and raw materials in the DSO organization.\r\r\rKnowledge of other techniques and disciplines in the QC department and a general understanding of how each discipline impacts the quality of drug substance manufactured at DSO.\r\r\rResearches and understands source regulatory documents to provide input into the development of processes and procedures used in the QC department (e.g. CFR, USP, EP, ICH, ISO).\r\r\rKnowledge of the elements of method verification and validation.\r\r\rProvides technical solutions to a wide range of difficult problems.\r\r\rIndependently determines and develops approaches to solve common analytical issues.\r\r\rProactively identifies and communicates issues such that they can be solved before they can have a detrimental effect on the organization.\r\r\rInstrumental in maintaining a work environment conducive to achieving departmental and site goals through emotional maturity, interpersonal communication, and conflict resolution.\r\r\rOperates effectively in a fast-paced work environment.\r\r\rTranslates ambiguous goals into actionable plans.\r\r\rMaintains flexibility in a dynamic work environment.\r\r\rEffectively communicates complex technical concepts to peers and management.\r\r\rCollaborates frequently and effectively with departments in the conduct of day to day operations including special projects.\r\r\rProvides constructive feedback on projects and processes.\r\r\rRepresents QC department on cross functional teams, both within and outside DSO.\r\r\rEffectively communicates in a diverse and multicultural environment.\r\r\rCommunicates effectively with regulatory inspectors.\r\r\rActs as Allergan representative to contract entities.\r\r\rInsures analysis in contract entities is conducted to Allergan standards of quality.\r\r\rAdvises contract entities during investigations of analytical results.\r\r\rAble to understand big picture and how individual tasks affect departmental and site goals.\r\r\rPrioritizes activities to meet critical objectives\r\r\r\r\r\r\r\r\r\r\r\r\rRequirements\r\r \r\rThe following listed requirements need to be met at a minimum level to be considered for the job:\r\r\rA Bachelors degree in natural sciences. Degree in chemistry or bio-chemistry strongly preferred.\r\r\rSix to ten years’ experience in a GMP pharmaceutical manufacturing and/or development environment.\r\r\rStrong HPLC skills.\r\r\rHigh level of understanding in chromatography data collection/processing software. Empower preferred.\r\r\rHigh level of understanding in GMP documentation.\r\r\rDemonstrated ability to retain flexibility in a dynamic work environment. \r\r\rMotivated to work in a team environment to deliver outstanding customer service.\r\r\rStrong commitment to safety\r\r\rAbility to interpret and evaluate data and summarize results.\r\r\rGood oral and written skills.\r\r\rPreferred Skills/Qualification\r \rThe below skills are attributes that may not be mandatory, but are definitely desired in the ideal candidate.\r\r\rDegree in chemistry or bio-chemistry strongly preferred.\r\r\rExperience with ELISA \r\r\rCE\r\r\rUV\r\r\rqPCR\r\r\rEducation\r\r\rA Bachelors degree in natural sciences. Degree in chemistry bio-chemistry strongly preferred.\r\r\r
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Company info

Allergan, Inc
Website : http://www.allergan.com

Company Profile
Allergan, Inc. operates as a multi-specialty health care company primarily in the United States, Europe, Latin America, and the Asia Pacific. The company discovers, develops, and commercializes pharmaceutical, biological, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, urological, and other specialty markets. It operates in two segments, Specialty Pharmaceuticals and Medical Devices. The Specialty Pharmaceuticals segment produces a range of pharmaceutical products, including ophthalmic products for dry eye, glaucoma, inflammation, infection, allergy, and retinal disease; Botox for certain therapeutic and aesthetic indications; skin care products for acne, psoriasis, eyelash growth, and other prescription and physician-dispensed skin care products; and urologics products. The Medical Devices segment offers a range of medical devices, such as breast implants for augmentation, revision, and reconstructive surgery, as well as tissue expanders; and facial aesthetics products. The company sells its products to drug wholesalers, independent and chain drug stores, pharmacies, commercial optical chains, opticians, mass merchandisers, food stores, hospitals, group purchasing organizations, integrated direct hospital networks, ambulatory surgery centers, government purchasing agencies, and medical practitioners. It focuses on eye care professionals, neurologists, physiatrists, dermatologists, plastic and reconstructive surgeons, aesthetic specialty physicians, urologists, urogynecologists, and general practitioners. The company has collaboration agreements with Molecular Partners AG; Spectrum Pharmaceuticals, Inc.; and Serenity Pharmaceuticals, LLC. Allergan, Inc. was founded in 1948 and is headquartered in Irvine, California.

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