This job was last updated on May 15, 2026 4:29 PM.

Key Responsibilities

• Author and submit revisions to controlled documents such as SOPs and controlled forms in support of GMP Operations.
• Support and perform equipment validation and qualification activities.
• Prepare, review, and/or audit technical documentation supporting GMP Operations.
• Lead, manage, and implement large cross-functional projects, evaluate current business processes, systems, and workflows.
• Analyze current processes to determine opportunities to optimize and improve processes and workflows.
• Implement Lean Six Sigma tools to optimize cost and improve efficiency.
• Develop a good collaborative working relationship with the Management team to help achieve department goals.
• Assist Site Managers with collecting and evaluating data.
• May also be required to support production activities on an occasional basis

Skills and Abilities

• Must be trained and understand continuous improvement principles like Lean Manufacturing, Theory of Constraints, etc. - Beginner
• Must be able to execute compendial procedures involving complexity. - Intermediate
• Must be familiar with cGMP and OSHA regulations. - Beginner
• Must be able to effectively communicate results, problems, or issues, verbally as well as in writing. - Intermediate
• Must be computer literate and savvy with MS Office applications, software programs related to LIMS. - Intermediate
• Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Intermediate
• Must follow safe practices as identified in the appropriate MSDS during working with chemicals, and must follow applicable state and federal regulations. - Beginner
• Must be capable of maintaining clear and concise laboratory records and communicating clearly both within and between departments. - Intermediate
• Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical settings and with method verification/validation concepts. Must be able to review laboratory records to ascertain compliance with applicable specifications, methods, and SOPs. – Beginner

Schedule

M-F

Pay

$23-27/hr - DOE