Level 1 Technical Writer
Basic Word Processing Activities - Staff will work with a subject matter expert and make document changes as outlined. Document will be reviewed for content, grammar, formatting, and spelling before being submitted or routed.
Level 2 Technical Writer
Advanced Word Processing Activities - Staff will work with a Subject Matter Expert or Project Manager to determine the needs of the client, Resource can learn a process and then create a working document with visual aids that is appropriate for the task and industry. Resource can initiate and obtain approval for document related change control cases.
Level 1 Validation Specialist
Validation Specialist with at least 5 years experience in equipment, process, or IT systems validation. Staff is capable of validating production and laboratory equipment as well as Technology Transfer projects, Process Mapping, and Temperature Mapping. Candidates can draft, route, and execute protocols with some guidance from Subject Matter Experts.
Level 2 Validation Specialist
Validation Specialist with more than 5 years experience in equipment, process, or IT systems validation; capable of validating equipment as well as Technology Transfer Projects, Process Mapping, and Temperature Mapping. Resource can draft, route, and execute protocols with little guidance and is capable of initiating and gaining approval for change control cases that support the validation effort.
Compliance Investigator with at least 5 years experience within a regulated industry. Candidate will posses several problem solving skills to determine the root cause of issues and will tailor a solution that fits the client's needs and organizational culture. Candidate is capable of determining needs of the client and presenting a plan with options and solutions that fit the needs of the organization.
Change Control Specialist
Change control Specialist with at least 5 years experience with FDA regulated industry in the area of change control and GMP compliance. Candidate is capable of initiating change control cases with little guidance from subject matter experts or project manager. Change control closure projects are also available with this resource. A Change Control Specialist can work with a backlog of open change control cases to get your organisation back in "control" of the process
Level 1 Project Manager
Project Manager with at least 5 years experience in Project Management. Project manager will manage low to medium complexity projects. Staff is capable of creating project charters and budgets. Project Manager can prepare and present project charters for approval. Candidate will plan, execute, and report status as required. Project Manager will work with Portfolio Manager or Site Management to achieve the site goals and provide project status and budget at defined increments.
Level 2 Project Manager
Project Manager with at least 8 years experience and PMP certification. Project Manager is capable of developing project ideas, project charters, project budgets and presenting to Steering Groups for approval. Senior Project Manager can execute projects, manage budgets, and milestones for medium to high complexity projects.
At Amris Consulting LLC our Automation and Building Technology division is focused on facility, utility and process systems automation.
Just a few of our many services include: