Formulation and testing of commercial, consumable reagents and calibrators for Healthineers and partner OEM instruments. Products support testing for drugs of abuse and therapeutic drug monitoring.
Following area procedures and manufacturing work instructions.
Proper documentation of production steps in batch records by following Good Documentation Practices.
Complying with the quality system and regulatory agency requirements: FDA, DEA, ISO, OSHA, etc.
Interaction with cross functional teams including Technical Operations, R&D, Planning, etc.
Partnership with support personnel to troubleshoot formulation processes.
Operation of manufacturing equipment.
Working independently and as part of a team.
Supporting continuous improvement initiatives in the formulation area.
Identifying problems as they occur and suggesting appropriate steps to solve them in situations where the problem is not difficult or complex.
Seeking advice and guidance on non-routine or problem areas from others.
Drive, execute, and implement lean manufacturing efforts, process improvements, cost reduction efforts, and supply chain initiatives.
Identify problems as they occur and suggest appropriate steps to solve them in situations where the problem is not difficult or complex.
Independently performs full range of standard work for the professional field. Refers complex, unusual problems to others. Identifies and resolves more complex problems and applies problem-solving skills to deal with most situations. Provides general guidance or train support and/or professional staff.
This position may suit you best if you are familiar with what is below:
Desirable experiences may include formulation, troubleshooting, production environment, regulatory requirements, SAP, Documentum, Microsoft software, good documentation practices, good manufacturing practices, general laboratory practices and chemical handling.
Candidate must also have strong communication abilities, interpersonal skills, strong work ethic and be a team player.
Required skills to have for the success of this role:
Bachelor's degree in Biology, Chemistry or Biochemistry or related discipline.
Minimum of 4-6 years of experience working in a lab.
10+ years relevant experience working in a Laboratory setting will be considered in lieu of a Bachelor's degree may be considered