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POSITION SUMMARY:
The Quality Systems Specialist 2 is responsible for the administration and maintenance of the document and record management processes. They maintain the Quality Management System (QMS) document and records archived by Halozyme. They support the training program activities for Halozyme. They participate and facilitate the change control process as it pertains to the eQMS process.
This position is located in Minnetonka, MN
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
Facilitate timely processing of new documents, document changes and change controls.
Coordinates with internal functional groups as needed.
Reviews internal documents prior to issuance to confirm compliance with Halozyme standards and works with document owners to resolve deficiencies.
Manages periodic document review process at Halozyme facilities.
Maintains QMS record storage, including organization and retrieval of records stored by Haloyme. Leads review of retained records for transfer to off-site storage locations or disposal as required.
Support processing of Change Controls, as needed.
As the Subject SME, delivers training to employees on the use of eQMS for document control, change control, and other systems as needed.
Enters and maintains data contained within the Enterprise Resource Planning (ERP) software system.
Prepares and reports quality metrics related to document control and other processes as needed.
Supports the administration of the electronic Quality Management System software.
Generates reports for management and inspections, as requested.
Supports audits (internal, client, due diligence, regulatory) as needed for document requests related to document control and training processes.
Supports validation and version upgrade activities for eQMS, LMS, and Enterprise Resource Planning (ERP) software, as needed.
Training Program Support
Assist training program activities as they pertain to the eQMS and document management process.
Provides input to support the continual improvement of document control, record management, and training processes.
Performs duties in accordance with the Company's QMS and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.
Maintains a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Performing other related duties, as assigned by manager.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
Minimum two years of college or work experience equivalent.
3 or more years in medical device or pharmaceutical document management, change control management, and training administration systems.
An equivalent combination of experience and education may be considered.
Strong computer skills. Fluent with Microsoft Office business software and use of information databases, particularly Microsoft Word, PowerPoint, and Excel.
Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, directives and guidance.
Experience with eQMS software for document and record management and training. Knowledge of ComplianceWire and/or MasterControl a plus.
Proven ability to communicate effectively; orally and written.
Ability to manage multiple tasks and projects, using negotiation skills to push tasks to completion.
Ability to prioritize workload to meet deadlines and to maintain high levels of quality and accuracy.
Able to work independently, as well as in a cross-functional team environment.
Customer Service oriented attitude and ability to exercise sound business judgment.
ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 5% of your time.