Job Description: Job Summary
Manage and evaluate the internal procedure processing through the Change Management System. Assist, organize and report handling processing, trending and maintenance of the selected quality system that may include but no limited to: Authorized Alternate Signature Registration, Organizational Charts, BCP, MFG Materials Lists, QSMR meeting packages, MTP’s, Review meetings packages, Change Control and other controlled documents. Maintain and secure designated Device Master Record Files. Manage and assure Device History Records are transferred to a secure and restricted area, as part of the quality system. Capable of independent action following established practices and procedures.
Principal Duties and Responsibilities:
• Manage and evaluate internal procedures processing through the Change Management System, including its revision, tracking (follow-up) and issuance.
• Maintain Device Master records and Device History Records as well as other quality system documents such as validation and project records, monitoring records, amongst other records. Being responsible for the retention of files as defined in corresponding procedure.
• Review change requests for accuracy and ensure the processing of all change orders are done in a timely manner. Review change request to ensure applicable statutory & regulatory requirements are identified, reviewed, and incorporated.
• Provide additional printed documents to the production such drawing as required.
• Notify the changes implementation (procedures, drawings and specifications) to appropriate departments. Maintain files updated with current revisions.
• Assist with the maintenance of the company intranet, Livelink web-based software to ensure the most current document revisions are available at all points of use.
• Maintain the assignment of control numbers for documents and validation protocols.
• Handle the verification of procedures, forms, blueprint, and PWIs as applicable to ensure current revision accuracy within physical documents and system.
• Complete typing and proofreading of procedures and documents, including requested changes to them.
• Maintenance of various databases such External Standards and Global Harmonization to ensure compliance to regulations such as indices used for procedures, drawings etc.
• Preparing and organizing documents for scanning and offsite storage archival and/or archival onto CD. Maintain storage logs.
• Process and distribute various document requests to departments as needed.
• Complete various projects as assigned by the supervisor in addition to general filing and copying.
• Performs other tasks within the work area, as instructed by the Supervisor or Designee.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence (i.e., knowledge, skills and abilities)
• Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship.
• Good verbal and written communication skills
• Good word processing and database skills
• Outstanding organizational skills and high attention to detail
• Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices a plus.
Education/Experience Requirements
• High School education or equivalent
• One to two years regulatory/quality or related experience and three to six months on-the-job training, or an equivalent combination of education and experience.
• Must be willing to work in any shift, including overnights.
Pay Details: $11.50 per hour
Benefit offerings available for our associates include short-term disability and additional voluntary benefits including medical, dental, vision, life insurance, commuter benefits and a 401K plan.
Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave and Vacation Leave or any other paid leave required by Federal, State, or local law where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance