Documentation Specialist Histogenics
THIS JOB HAS EXPIRED Job Summary
The QAD Specialist II reports to the QAD Supervisor and is responsible for the maintenance and improvement of Histogenics Corporation's Documentation and Records Management Quality Systems in compliance with company and regulatory policies and procedures. A high degree of flexibility regarding daily changes in priorities is essential and normally receives no instruction on routine work, but general instructions on new assignments.
Essential Duties & Responsibilities
DOCUMENT / CHANGE CONTROL
Administer Change and Document Control programs in accordance with internal and regulatory policies and procedure.
Process documentation changes in accordance with internal policies and procedures. Works and interacts with technical staff, or subject matter experts, to resolve documentation issues.
Assist in the establishment of weekly change control (document) processing priorities.
Maintains all Quality Assurance Documentation files (paper and electronic) in accordance with internal procedures.
Report status of change control for departments to FAM (weekly/monthly/quarterly).
Copy, distribute and maintain documents in accordance with internal procedures.
Issue numbers on all new master documents.
Assure completeness of all documentation.
Administer record control procedures in accordance with internal procedures and regulatory policies.
Maintains control of External Standards in accordance with internal procedures and regulatory policies.
Ensure all documents are scanned to PDF in accordance with internal procedures and regulatory requirements.
Indexing of archival and retrieval of completed validation, technical reports and batch records.
CONTROL OF LABELS / BATCH NUMBERS
Issue batch records to manufacturing.
Issue, review and approve product labels issued in-house including label inspection / verification, reconciliation and destruction.
Create and control the electronic files for the final packaged product labels.
Report status of outstanding batch records, labels, logbooks, etc., to FAMs.
Release of all raw materials for GMP use and maintain an inventory system.
Create and issue laboratory notebook and logbooks according to internal procedures.
Create new/revise existing SOPs, training guides and checklists as necessary.
Evaluate new processes and procedures to be used in QAD.
Provide training and guidance to various departments on QAD systems.
May provide services to other functional areas as required.
Physical requirements may include lifting up to 40 lbs and long periods of standing.
Education/Special Training Required
High School degree (or equivalent) and a minimum of 2 years related experience in documentation, QA or related field preferably in the biotech or medical device industry or an Associates degree (or equivalent) and a minimum of 0 to 2 years experience in documentation, QA, or related field.
Qualification/Work Experience Required
Prior experience in medical device or other GMP-regulated industry is preferred.
K nowledge of ISO, FDA and cGMP concepts and guidelines.
Must have strong skills in organization, record keeping, communication, and excellent writing, grammar and proofreading skills.
Exceptional attention to detail is essential.
Strong oral and written communication skills are required as this position will interact with individuals at all levels of the company as well as external individuals.
Strong Project Management and Organizational skills are a must.
Competence in Microsoft Word, Excel, Access, PowerPoint, Outlook and Adobe Acrobat.
Works on complex problems, exercising judgment within defined practices and policies.
May determine methods and procedures on new assignments and may provide guidance to other lower level personnel.
Must be able to work in a team environment, demonstrating ability to take direction and work with a variety of people.
Candidate must be flexible and able to adapt to changes in priorities.
||830 Winter Street |
Waltham, MA 02451
|Employment Type:||Full Time|
THIS JOB HAS EXPIRED
Beta Test / Clinical Trials Investors: Boston Millennia Partners
, Inflection Point Ventures All Jobs: at Histogenics
|Headquarters:||830 Winter Street|
Waltham, MA 02451
|Industry:||Medical Devices and Equipment|
|Company Profile:||Histogenics (www.histogenics.com) in Waltham MA is a tissue regeneration company developing breakthrough treatments for long-lasting joint repair. Its cartilage regeneration products apply advanced cell biology, tissue engineering and materials science in the repair of injured or diseased joint, to restore joint function and prevent degenerative disease.
We are moving into Phase III of Clinical Trials and looking to add to our team. Please join us during this exciting time
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