Laboratory Analyst VI

Role Summary

The Laboratory Analyst VI is an integral part of the Quality team based out of the US - Willow Island, WV site.

Responsibilities

• Receives and prepares samples for analytical testing and initiation of stability studies.
• Performs physical testing of routine and non-routine samples with little supervision including but not limited to raw materials, in process testing, API & finished good release and stability testing.
• Supports the site quality, safety and production needs and goals compliantly.
• Works within cross-functional teams.
• Coordinates own work assisting the lab to complete priority projects.
• Completes all activities following site cGMP, Safety requirements and Phibro Standards.
• Conducts laboratory activities related to experiments, studies, and projects in support of production, laboratory, or other Phibro groups.
• Understands and follows cGMP regulations. Data maintenance and record keeping are in accord with GMP and SOPs. Participates in projects and follows through to completion. Supports laboratory operations using technical ability to run routine samples independently. Recognizes abnormal results and/or instrument problems and reports them to supervision providing input to cause and possible solutions.
• Performs routine tests and experiments following compendial or standard procedures.
• Has an understanding of Lean & 5-S concepts.
• Sets up, adjusts and operates laboratory basic equipment and has experience with advanced equipment (Viscosity, Karl Fischer, UV/VIS, HPLC, GC).
• Maintains and follows Standard Operating Procedures; generates protocols and executes projects, may lead a project and be responsible for completion.
• May assist with writing and revising procedures; may be assigned to projects with method modifications under close supervision.
• Records test results on standardized forms and prepares reports; creates charts/graphs to aid data interpretation. Completes investigations into aberrant data and prepares summary reports; applies problem-solving techniques in a team environment.
• Acts as a Subject Matter Expert in Procedures for their area, providing training in and out of their department.
• Maintains a safe and clean working area and assists others; collaborates with Analysts, Scientists and Management for receipt and preparation of QC Test Samples and Stability study samples.
• Follows good documentation practices and Phibro Core Beliefs; identifies EHS hazards and proposes solutions to improve lab/safety compliance.

Qualifications

• Analyst III: High School degree or equivalent with ~10 years lab experience in an FDA-regulated environment; or 2-year degree with ~3 years’ experience; or B.S. degree with ~1.5 years of experience.
• Analyst IV: High School degree or equivalent with ~15 years lab experience in an FDA-regulated environment; or 2-year degree with ~5 years’ experience; or B.S. degree with ~3 years of experience.
• Analyst V: High School degree or equivalent with ~20 years lab experience in an FDA-regulated environment; or 2-year degree with ~10 years’ experience; or B.S. degree with ~5 years of experience.

Skills

• High degree of time management and ability to handle multiple priorities and projects.
• Excellent written and verbal communication; proven ability to work effectively in a team.

Education

• Analyst III, IV, or V level as described above.

Additional Requirements

• Operations of laboratory equipment; required to bend, sit, stand, talk or hear, use hands, walk, and have various vision abilities; ability to work weekends and off shifts as needed.