QUALITY SYSTEMS SPECIALIST
Amicus Therapeutics is a late-stage biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule, orally-administered drugs known as pharmacological chaperones, for the treatment of a range of human genetic diseases and diseases of neurodegeneration.
Amicus is committed to developing its pharmacological chaperone technology and has built a robust clinical and preclinical pipeline of small molecule, orally-administered agents.
As part of Amicus' strategic business plan, the Company is focused in three key areas:
• The Phase 3 development of its lead program, AT1001 for the treatment of Fabry disease;
• Advancement of pharmacological chaperones used in combination with enzyme replacement therapies (ERT) for the treatment of lysosomal storage diseases; and
• Advancement of its lead pre-clinical programs that utilize its pharmacological chaperone technology for the treatment of diseases of neurodegeneration.
OPPORTUNITY: QUALITY SYSTEMS SPECIALIST
The Quality Systems Specialist (QSS) will be responsible for supporting the administration and oversight of Quality Systems within the Amicus Quality Assurance Department.
This position will be team-based and include members of both QA Clinical and QA Manufacturing. Overall supervision will be provided by the QA-GMP Director. Responsibilities include but are not limited to:
o Organization and maintenance of assigned QA-GXP department documentation (e.g. Internal and vendor-based Change Controls, Non-Conformance Reports, Deviations, Audit Documentation, SOPs and supporting CMC files, etc.).
o Assisting in the development of templates for selected quality metrics as needed (e.g. CAPA reports, monthly QA-metrics reports, etc.)
o Maintaining department tracking logs (e.g. Quality Metrics, Audits, etc.).
o Assist with organizing and cataloging the physical training files according to QA plan
o Assist with maintaining the internal training tracker spreadsheets with training record information, ID missing information and execute a corrective plan in collaboration with QA team
o Assisting in the development of graphs and charts of all Quality metrics for presentation to senior management
o Assisting with the preparation/updating of quality metric reports.
o Assisting with the preparation, updating and tracking of audit/inspection reports/CAPA Plans as directed.
Additional Responsibilities and Expectations:
o Photocopying, filing, faxing, scanning, and archiving department documentation (e.g. SOPs, Batch Records, Guidance Documents, Reports, etc.).
o Cataloging and communicating deficiencies in Quality-related documentation to the QA-GXP team in a timely manner.
o Participation in QA departmental meetings as required.
o Exposure to sensitive information will necessitate a high level of confidentiality, and a considerable use of tact, diplomacy, and quality judgment.
Qualifications:
A successful candidate should have:
o A B.A. /B.S. in science-related field. Degree in another discipline if sufficient technical depth has been achieved by professional experience.
o Demonstrated knowledge in the regulatory areas of concern to Amicus (e.g., FDA/EU Regulations, 21 CFR Part 11, ICH-GCP).
o Demonstrated experience with pharmaceutical quality systems (clinical, pharmaceutical, biopharmaceutical, consumer healthcare) to include non-conformance investigation process; CAPA; change controls, vendor management, and Quality metrics management and reporting
o Solid written and verbal communication skills, analytical and problem solving skills.
o Flexible, highly motivated, with strong organization skills and the ability to multi task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
o Proficient Computer Skills: Specifically MS Word, MS Excel, MS PowerPoint, MS Project, SharePoint a plus
Qualified candidates please submit your résumé to:
Email: careers@amicustherapeutics.com
Amicus Therapeutics is an equal opportunity employer.
NO PHONE CALLS PLEASE
Please apply directly to
Tony Castellazzo
Director, Quality Assurance - GMP
Amicus Therapeutics
6 Cedar Brook Dr
Cranbury, NJ 08512
609-662-5003
acastellazzo@amicustherapeutics.com
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