Description:
Performs laboratory testing within a GMP environment in support of one or more of the following areas; raw materials, in-process product, finished product, stability, and/or validation. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Interprets data output to determine conformance with product specifications. Reviews and verifies data generated by others to determine conformance with product specifications. Understands internal business process, to make appropriate prioritization of their assigned work duties. Has experience and command of multiple laboratory techniques to perform them with minimal error. Can train other laboratory personnel on any technique they currently have in their training matrix.
Responsibilities:
- Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
- Proposes and implements changes to maintain procedural requirements.
- Performs analytical test methods as written to support product/material release with minimal error.
- Proposes and implements changes to improve laboratory techniques and methodology.
- Can independently troubleshoot and resolve analytical techniques and instrument issues.
- Interprets experimental data for conformance with product/material specifications.
- Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.
- Initiates appropriate exception documents in accordance with procedural requirements.
- Implements and ensures improvement ideas are completed to facilitate team objectives.
- Proposes and implements scientific protocols to determine exception event cause.
Qualifications:
- Bachelor's degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 6 years of experience in related field.
- Master's Degree in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 4 years of experience in related field.
- PhD in Science, preferably Microbiology, Biology, Chemistry or Bio-Chemistry with 2 years of experience in related field.
- Manages multiple priorities and comply with deadlines.
- Maintains their certifications as needed for assigned job tasks.
- Demonstrates strong analytical skills and logical thought process.
- Extensive experience and expertise in instrument and equipment qualification.
- Proven experience in software qualification.
- Demonstrated ability to manage change controls as the owner and conduct comprehensive impact assessments.
- Experience conducting data integrity risk assessments.
- Strong project leadership, communication, and results-driven execution skills.
- Experience in software qualification.
- 4 years in equipment qualification - Required.
- Experience in direct process / manufacturing areas.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.
