Job Description
Job Description
SUMMARY
This position will provide support to ensure the organization maintains compliance with Quality Systems,
current Good Manufacturing Practices (cGMPs), current Good Tissue Practices (cGTPs), and in adherence
with all applicable Federal, State, local, international, and industry regulations and standards. This
individual will perform a variety of activities needed to establish and maintain compliance; including
responsibilities associated with the quality assurance tasks.
Essential Responsibilities
Perform job functions in compliance with internal Standard Operating Procedures, Current
Good Manufacturing and Tissues Practices, all Federal and State regulations and accrediting
agency standards.
Assist in the management of the electronic document management systems including
management of the site training records.
Review batch records and release products.
Assist with the initiation and risk classification of deviations.
Inspect and release incoming materials.
Ensure the electronic copies of SOPs, training materials, validation plans and other
regulated documents are maintained.
Assist in the management of the library of printed documents, manuals and reference
materials.
Work with departments to coordinate, schedule, and prepare for document release and
training activities for new or revised procedures, competency assessments, annual GMP
training and all other document release and training items as deemed necessary.
Assist in the creation of SOPs, forms, documents and training materials.
Assist in the creation, revision, and approval (for minor changes) of SOPs, policies, forms,
etc.
Participate in customer and regulatory audits.
Assist the QA/RA department with process improvement activities.
Assist with special projects as assigned.
Perform all other duties, at the discretion of management, as assigned
Resolves conflicts with team members and involves functional management as required.
Company DescriptionSince 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award-winning, dedicated team of recruiting professionals specialized in technology, are great listeners and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Company Description
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award-winning, dedicated team of recruiting professionals specialized in technology, are great listeners and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.