- This position will provide operational support for manufacturing team and act as a liaison for production in designated operational area.
- This role will also provide support to other operational areas within manufacturing as required.
Reports to: Head of Manufacturing Area.
Main Job Tasks:
- Liaison between Product Support and Manufacturing for one or more of the following and will act as back-up and/or assist with others:Formulation Ticket Review
- Formulation Ticket Data Trending
- Batch record review
- Batch Record Data Trending
- SAP Purchase OrdersLIMSPEMS
- Assist with revising and creating documentation (SOP, batch records, reports, notebooks) associated with the manufacture of product
- Participate in pre-planned process improvements and cost reduction projects into manufacturing.
- Work within quality system
- Support of Health Authority inspections.Perform area equipment and process validations in accordance with validation procedures requiring minimal direction. Hands-on manufacturing within the given area for production coverage
- Support activities in other departments as instructed by supervisor or manager.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.Incorporates the company Way and 10 Essentials in all activities and interactions with others.
Travel: up to 5%. Will need to be able to acquire all documentation to travel locally and internationally.
Development of People:
Knowledge, Skills and Experience:
- High School diploma or equivalent with a minimum of three (3) years relevant manufacturing experience or a Bachelor’s degree or equivalent in a science or engineering discipline with one (1) or more years of experience.
- Possesses technical and systems knowledge and is able to research information outside of knowledge base.
- Requires functional understanding of cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines.
- Ability to understand and execute established written instructions is essential.
- Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment.