Objective: Uphold standards as required in a GMP environment. Strict attention to detail is required for the timely release of final product.
The responsibilities of this role include the review of manufacturing records, the preparation of customer facing documentation, the implementation of change control, the coordination of incoming documentation, support for customer audits, support for site quality training and the filing of controlled documentation utilizing LIMs, AGILE, Trackwise, Excel, Power Point and MS Outlook.
The individual must be team orientated to achieve team goals and be self-motivated to meet developmental goals in an intensely focused environment.
Daily interaction is required with production team members and quality team members to assist with the timely resolution to quality issues and to improve current documentation practices.
Requires flexibility to work all 3 shifts, based on business needs.
Experience in a role associated with GMP manufacturing environment
Experience in an administrative capacity with organizational skills and high attention to detail
Possess a positive and professional attitude
Possess effective communication skills verbally and written
Experience with practical process improvement (PPI) and/or project management
Effective presentation skills are required to participate in PPI and site training activities
Interact effectively with various levels of the organization for problem resolution
Experience in LIMs, AGILE, Trackwise, Excel, Power Point and MS Outlook
High School diploma required
Associates degree with 2 years' experience in GMP environment preferred
Minimum of 1 year degree in business or technical discipline and/or minimum of 1 year experience in a role which demonstrates attention to detail with high standards to error free work.