• Responsible for overall coordination of controlled documents within the company's Document Control system • Maintain and improve processes associated with an electronic document control system within GLG. Ensures timely completion and version control of all new and revised documentation • Work cross functionally to ensure change orders are executed in a timely manner • Responsible to the accuracy of documentation per approved Standard Operating Procedures, GMP and internal change control • Supports internal and external audits, helps with the coordination of document requests • Aids in the responses to internal and external audits as they related to the Document Control process • Supports users
requests for documents • Performs self-audits and ensures that current revision is available at point-of-use in a timely manner • Maintains quality records per applicable SOPs • Responsible for coordinating document change orders, collaboration, approval, release and retention.
• Other duties may be assigned as deemed necessary by Quality management Required Qualifications: • Strong communication (verbal and written) and interpersonal skills • Attention to detail and timeliness are critical • Computer Skills: software proficiency in Microsoft Office Suite is required • Previous GLG experience is a plus • Must build rapport across functional teams within the organization • Bachelor’s Degree
or equivalent experience • Minimum of 2 years of experience in Document Management System • Through understanding of the regulations and regulatory processes for document control/ management • Must operate through collaboration and transparency • Experience in c GMP/GDP/GCP environments, GMS, ISO 13485 and FDA regulated industries is preferred • Any Medical Device related certification is a plus.
around the world? If so, then we want you on the Imbed Biosciences team! Job Summary We are looking for a highly motivated Production Technician with experience working in regulated manufacturing environments. The Production Technician will assist Manufacturing team in production of medical devices.
The successful candidate will work within a small, focused, high-energy, team environment and maintain a strong sense of shared responsibility and shared reward to make work fun and interesting. This position allows for flexible start times. Roles and Responsibilities Work with Medical Device Production team in a moderate-volume medical device production environment to fabricate polymeric
films Perform and assist in daily laboratory tasks and work flow, record data, and communicate results Ensure quality control of materials and end products of the company in a consistent manner Minimum Qualification and Experience Education/Experience: A four-year degree (BS) in sciences, with 1-2 years’ work experience in a chemistry/biological laboratory or production environment; or a two-year associate degree in sciences with 2-4 years’ work experience; or a high school diploma (or equivalent) with 3-5 years’ work experience Experience working with chemical reagents in laboratory setting while adhering to safety, environmental and/or health protocols Ability to follow standard operating procedures
and lab work instructions, and maintain daily records in a timely and reliable fashion Strong communication and problem-solving skills Ability to arrange material and goods, maintain a clean workplace and set up the environment for packaging Preferred Experience Ability to communicate in a clear and concise manner Practical knowledge to identify problems with equipment and materials Working under a quality management system such as ISO 9001 or 13485, or similar Why You Should Apply Imbed Biosciences, Inc.
is a growing medical device company with commercial products being sold in the U. S. and overseas, and with many exciting products in the development pipeline.
In fact, we are growing so quickly that we are relocating in Q2 2022 from our current Fitchburg, WI, location to a brand new, larger, completely redesigned location in Middleton, WI! At Imbed, we understand the mounting pressures on our current and future employees' families as a result of the COVID-19 pandemic. We offer flexibility, excellent salary and benefits, professional growth and development, and a team that will propel you to succeed! If you are looking for a place to grow, thrive, innovate, make a difference in patients' lives, and enjoy the work you do, then we want you on the Imbed team!
