Scope:
This position is responsible for providing communication management, schedule management, document management, and other supportive duties for QA Project Managers. This role assists in making the QA Project Mangers more productive and capable. This position plays a critical role in the organization which ensures customer needs are met and Quality Project Managers can efficiently execute their role. The position requires a strong attention to detail and strong organizational skills. The position is critical to tracking the status of a significant number of documents and ensuring the right customer gets the right answer at the correct time.
Accountabilities:
Document and Office Management - Daily, 60%
- Receive and log customer requests
- Developing and maintaining department files and filing systems
- Coordinating projects delegated to other areas (duplicating, travel services, mail services, etc.).
- Operating and maintaining a variety of office equipment.
- Scan documents for upload to the customer
- Interface with shipping to ship samples to the customer
- Collect data for the QA PM to analyze (could be date from BPRs, Trackwise, etc).
- Pull analytical data (DIRT reports) to aid QA PM document approvals
- Collect annual data for CARES Act reporting
- Input monthly customer metrics directly into their collaboration site.
- File documentation in the Site GMP Library
- Accept additional tasks as assigned based on the abilities of the individual
- Track document status
- Due date
- When Routing for approval
- When ready for customer
- When customer approved it
- Upload and download documents to and from the customer shared data area
- Remove password protection for PDF documents from Regulus uploaded to Customer
- Route documents for review and approval in Regulus
Communication Management - Daily, 30%
- Communicating daily with the area management to keep them informed of important activities.
- Prepares documents, letters, presentations, and other correspondence
- Prepare metric slides (for review by QA PM); help maintain customer metric data
- Draft memos and declarations based on previous year’s examples (for review by QA PM)
- Editing and proofreading documents
- Draft Quality Control Plans for commercial products that do not have them.
- Preparing materials for distribution and presentation at meetings
- Preparing agendas and minutes
- Handling email and voice mail responses on an as needed basis
- Updating and maintaining the area's shared information
- Interacting frequently with QA management and external customer team members
Schedule Management - Monthly, 10%
Each individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the SISPQ (Safety, Identity, Strength, Purity, Quality) of the products manufactured at client site..
This includes but is not limited to the following:
- Maintaining the daily calendars of one or more department members
- Arranging travel and scheduling requests for key department members
- Scheduling ad hoc and/or recurring meetings and webex/teleconferences, including customer and internal visits
- Planning events and coordinating activities for groups of people at on- or off-site locations
- Track due dates of items assigned to QA PM (CAPAs, deviations, SOPs, etc) and feed standard tasks and document approvals in order of priority.
- Plan administrative details of customer audits
- Collect background data to help prepare for supplier audits– Deviation history, recent COAs, item codes received, etc
Each individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the SISPQ (Safety, Identity, Strength, Purity, Quality) of the products manufactured at client site..
This includes but is not limited to the following:
- Adherence to all written instructions.
- Timely reporting of all deviations to supervision.
- Training on each activity is completed and current and that each employee understands their assigned duties.
- Strict documentation practices are followed to ensure that all steps of the operation are appropriately documented.
- Ensure to maintain the work area in a state of cleanliness and sanitation through good housekeeping practices and applying good personal health practices.
- Ensure the security and safety of the product through the reporting of any potential risk to supervision immediately.
- Ensure the safety of the personnel and product by wearing proper PPE (Personal Protective Equipment) according to the operation being executed.
- Each individual should report any action that they believe could impact the SISPQ of any product immediately to supervision.
Environmental, Safety, Health, & Security (ESHS)
- Adhere to ESHS programs, rules, & procedures.
- Assume personal accountability for individual behaviors related to ESHS activities.
- Have the appropriate knowledge and tools prior to performing a task.
- Complete all required ESHS training and remain current with applicable learning plans at all times.
- Report all injuries to Employee Health Services or Security and supervision within the same shift of the incident occurring.
- Inform direct supervision of any ESHS hazards or concerns in the workplace.
- Provide feedback and coaching to coworkers on both safe and unsafe behaviors and conditions.
- Actively participate in the ESHS management system as directed by supervision.
- Associate’s degree or greater
- Ability to work independently and in a team environment
- Computer skills, including Microsoft Office Products, including Outlook, Word, Excel, PowerPoint; experience with or ability to learn Trackwise, Regulus, and other computer programs.
- Good communication skills
- Ability to organize and track large amounts of information
- Prioritization and multi-tasking skills
- Ability to maintain confidentiality
- Verbal and written communication skills
- GMP (Good Manufacturing Practices) highly desirable
Contract
Perth, Western Australia, Australia
