Quality Assurance Operations Manager

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 Operations Manager in our QA Department, located in our Port Washington, NY facility. Position Qualifications: * Responsible for quality within PS NY operations (QA Materials Release and Batch Release).--Continuously safeguard quality and compliance (e.g. FDA) in production areas so that ALK will always fulfil regulatory requirements for the production of pharmaceutical products.* Supervise QA operation team and maintain oversight throughout PS NY operations* Work with QA Canada and QA OKC to align procedures where possible* Work with QA Global to harmonize site SOPs with applicable Corporate SOPs (CSOPs)* Maintain QA oversight of QA operations functions assuring clear roles and responsibilities in all QA operations areas:* Batch Record Review* QA Materials Receiving* Operations inspection/floor audits* Ensure that Health Authority requirements and trends with special focus within the areas of quality assurance/compliance are monitored and implemented* Develop, implement & monitor KPI's for the QA Ops Team and review those KPI's with the team to ensure KPI targets are met.* Ensure timely release of Raw Material to production* Ensure timely release of Finished Goods once records are received* Reinforce Quality Standards proactively through execution or management of site compliance projects-- Lead or support writing Deviation investigations, in depth review and evaluation on changes and identify relevant effective CAPAs as needed.Education: * Minimum BS in Biology, Biochemistry, Chemistry or alikeExperience: * Minimum 3-5 years' experience in the pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs * Minimum 2 years experience with regulatory inspection (faced inspections)* Experience with handling compliance risk by balancing Quality/Delivery/Cost* Minimum 2 years management experience -- Pharmaceutical and medical device business understanding including in-depth knowledge about regulatory and GMP requirementsALK 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 Assurance Operations Manager, Executive , Port Washington, New York