Description
The Corporate Quality Systems & Services Department is responsible for ensuring compliance of all Ikaria locations with the US Food and Drug Administration, International Standards Organization, and other applicable international regulations. This position provides for the management and control of Corporate Quality Documentation, including the documents, records and associated processes.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
* Establishes and maintains a central repository, including history files, for all controlled Quality & Regulatory documents and records.
* Implement and control the Corporate Document Management System as both a paper system and electronic system (Master Control Documents).
* Perform various duties essential to the implementation and maintenance of a regulated documentation system, including coordinating efforts for the control of new and updated Quality System procedures.
* Manages, assigns and prioritizes the document activities to the appropriate Corporate Document Management staff as required to support the system.
* Create and revise controlled documents, i.e. SOPs.
* Ensure changes and processes are properly implemented and documented.
* Prepare and review Standard Operating Procedures and ensure the submitted corporate procedures meet the requirements of Ikaria document control procedures.
* Assure controlled documents are appropriately reviewed and approved prior to implementation via the change control process. Interface with other department staff to answer questions regarding SOPs and documentation.
* Maintain controlled documents in strict compliance to departmental policies, regulations and standards.
* Identify, generate and publish metrics and reports related to the quality system.
* Maintain various quality systems logs and document indexes associated with the Corporate Document Management system and change control.
* Facilitates the effective processing of quality system documents to ensure they are maintained and archived in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body.
* Executes the retention policy system and process for all documentation, both manual and electronic. Develops QA procedure(s) specific to QA document retention.
* Supports/Conducts orientation and in house, site specific training on Quality documentation SOPs and the process. Develops, maintains and delivers training materials.
* Routinely conducts searches of Regulatory websites for new and revised regulations and standards. Establishes and maintains a QA archive/library of Quality reference standards, articles, journals and textbooks to enhance the department's knowledge of quality systems and strategies.
* Maintains an archive of Medical and Engineering literature pertinent to company devices.
* Other duties as assigned.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
* A minimum of a Bachelor's Degree in a Science/Engineering or other relevant discipline
* 5 - 7 years of overall experience with document/change control process and Quality Systems, preferably in the medical device/pharmaceutical industry.
* Excellent supervisory skills with 2 - 4 years direct management experience of 1 or more individuals.
* Demonstrated knowledge of QSR/GMP (21 CFR Part 210, 211, 820) regulations and ISO (ISO 13485) standards is required.
* Knowledge of 21 CFR Part 11 and Computer/Quality System Software validation, preferred.
* Proven ability to make improvements in processes and systems in a Quality Systems environment
* Worked with/established an Electronic Documentation system such as Documentum, Agile, Master Control or equivalent.
* Strong oral and written communication skills and effective interpersonal skills.
* Ability to multitask, prioritize and meet deadlines.
* Ability to meet deadlines
* Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel) and Adobe Acrobat/Acrobat Pro is required.
* Ability to communicate well with all levels of staff and organize inter-departmental meetings will be required.
* The ability to work well independently and follow through in a timely manner will be needed.
* The ability to pay attention to details and accuracy while being flexible; able to adapt to changing priorities is required.
Ikaria is an equal opportunity employer. Applicants receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, veteran status, pregnancy, sexual orientation, gender identity, or membership in any other class protected by applicable federal, state, local or foreign anti-discrimination laws.
Type Full-time
Location Corporate
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