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Quality Engineer

Company: ALK Abell--
Location: Port Washington
Posted on: February 25, 2021

Job Description:

About ALK ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies.--ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) - a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.Since 1923,--we have been--working to improve the--quality of life for--allergy--patients--by developing--products that--target the cause--of allergy. With over 2,200 employees and subsidiaries, production facilities and distributors worldwide we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on--NASDAQ--OMX--Copenhagen--(OMX:--ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada. ALK has an opening for a full-time Quality Engineer in our Quality Assurance Department, located in our Port Washington, NY facility. Position Qualifications:* Quality Management of computerized systems in the Pharmaceutical Industry* Able to interpret 21 CFR part 211 and 11 in relation to computerized systems* Identification of electronic records and signatures in computerized systems* Mapping of process data flows to establish archiving of data and retention periods.* Change Management of Computerized Systems to set the effort of validation for the identified change* Experience in GXP evaluation of the Computerized systems to ensure adherence to the FDA regulations and data integrity requirements* Create and execute a risk assessment for computerized systems* Create Standard Operating Procedures, Work Instructions, and other documents as necessary for establishing and maintaining an IT audit program to ensure system(s) compliance* Schedule, Perform and Report on audits of ALK systems as needed* Systematically track audits and CAPAs for effectiveness* Perform and review deviation investigations as needed and ensure that proper corrective and preventive actions are implemented* Ability to lead or execute compliance projects for Americas sites as needed* Support Quality Assurance and other personnel in efforts to assure regulatory compliance* Assist during inspections by Regulatory Authorities* Other duties as assignedEducation:-- Bachelor's degree in Science, Information Technology or equivalent experience related to IT System Development, Implementation and/or Validation.Experience: * 2 - 5 years of related experience in operation or with IT systems in a regulated industry* Working knowledge of CFR Parts 11 & 211* Work experience with LIMS preferred* Knowledge of SAP & ICH Q10 a plus* CQA or CISA preferredALK is an equal opportunity employer with competitive pay and excellent benefits including medical, dental, vision coverage, life and disability insurance, 401k plan with employer contribution, 12 company paid holidays per year, and up to 2 weeks' paid time off in the first year of employment with the company!www.alk.net/uswww.alk.netALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Keywords: ALK Abell--, New York , Quality Engineer, Engineering , Port Washington, New York

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