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Quality Assurance Specialist

Company: Chartwell Pharmaceuticals
Location: Congers
Posted on: November 22, 2021

Job Description:

PLEASE READ > > > > > > > > THIS IS A PHARMACEUTICAL POSITION NOT A SOFTWARE POSITION!Dear Candidates, please respect our position, experience, and location requirements before you apply to the position and we incur the cost.AWe will ONLY consider candidates that meet ALL of the requirements, so please apply if you do. Thank you for your interest and understanding.===========CHARTWELL PHARMACEUTICALS:Chartwell Pharmaceuticals, LLC is a privately-held, US-based generic pharmaceutical manufacturer with manufacturing in Congers (Rockland County), New York, R&D Operations in Israel.AAAWith over 250 ANDA listings in the FDA Orange Book, Chartwell is rapidly growing and transforming our business as a full-scale Generic Pharmaceutical Manufacturer and Distributor serving the Retail, State and Federal Government Markets under the 'Chartwell Rx'A labels.AAThis is an excellent opportunity to get in on the ground-floor with a fast-growing and dynamic generic pharmaceutical company!Position SummaryThe Quality Assurance Specialist will support various Generic Pharmaceutical Quality Operations relating to Commercial and/or R&D activities, originating from manufacturing, laboratories, and 3rd party facilities.AThe candidate will ensure high standards of compliance and recommend and implement continuous improvement initiatives as necessary.Job Duties & ResponsibilitiesQA support and oversight of cGMP manufacturing, packaging, and analytical activities.Ensure quality system excellence, including change control governance.Ensure quality operations support for R&D projects, and R&D-to-commercial transition.Key contributor to quality and technical aspects of ANDA site transfer into owned and 3rd party facilities.Support all regulatory filings and required reporting.Responsible for, or supporting one or more key programs and functions such as Annual Product Review, Investigations, batch record review, label management, product complaints, process improvement, cGMP training, etc.Essential QualificationsMinimum of 3 years of experience in a cGMP Quality environment and in a relevant QA Technical Leadership role.Generic pharmaceutical manufacturing and QA experience is a MUST.Thorough knowledge of cGMPs and relevant regulatory requirements.Knowledge in change management, especially for ANDA technical site transfers.Superior interpersonal and communication skills (verbal, written and presentation).Highly ethical and transparent, with professional sensitivity and care for confidentiality.APLEASE NOTE:AThis position is based in Congers, NY and we only seek candidates from the New York Metropolitan area.Candidates must meet all of the criteria in the qualification questions.Sponsorship is not available for this position.Agency referrals are not accepted.by Jobble

Keywords: Chartwell Pharmaceuticals, Yonkers , Quality Assurance Specialist, Other , Congers, New York

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