Job Description

Pay $42-$45 per hr. DOE.

The Quality Systems Contractor is responsible for general support of the administration and maintenance of the document management and training programs. They support the Quality Management System (QMS) document and records archived at the San Diego/Minnesota facility. This individual will also perform a range of support activities within the Quality Systems group which include, but are not limited to: Complaint Handling, Records Administration, Quality Events, and audit support.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:

• Document Control Support
• Facilitate timely processing of new documents, document changes and change controls.
• Reviews internal documents prior to issuance to confirm compliance with company standards and works with document owners to resolve deficiencies.
• Supports the periodic document review process to ensure timely completion of reviews.
• Complaint Handling Support
• Supports entry of product complaint reports into eQMS.
• Training Program Support
• Supports eQMS training program (MasterControl/Compliance Wire) to ensure training is deployed to appropriate personnel.
• Provides supplemental support for the annual training plan review process.
• Records Management Support
• Supports QMS record storage, including organization and retrieval of records stored at the San Diego facility. Participates in the review of retained records for transfer to off-site storage locations or disposal as required.
• Supports audits (internal, client, due diligence, regulatory) as needed for document requests related to document control and training processes.
• Provides input to support the continual improvement of document control, record management, and training administration 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.
• Other duties as assigned.

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 administration. Knowledge of ComplianceWire and/or MasterControl a plus.
• Customer Service oriented attitude and ability to exercise sound business judgment.
• Proven ability to communicate effectively; orally and written.
• 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.
• Ability to maintain confidentiality and discretion in business relationships.

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