What are the responsibilities and job description for the Document Control Specialist - Quality Systems position at Planet Pharma?
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 :
Salary : $42 - $45
