Role Summary
The Laboratory Analyst III is an integral part of our Quality team based out of our US - Willow Island, WV site. The Laboratory Analyst position supports the Medicated Feed Additives (MFA) business of Phibro in Willow Island, WV. The Quality Control laboratory provides testing and release support for the Willow Island manufacturing 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 and has applied skills related to Lean & 5-S.
- Sets up, adjusts and operates laboratory basic equipment such as balances, pH meter, sieves, ovens and has an understanding and has used advanced laboratory equipment such as Viscosity, Karl Fischer, UV/VIS, HPLC, GC.
- Maintains and follows Standard Operating Procedures dealing with their work area and can apply knowledge to assist in other work areas.
- Generation of protocols and execution of projects with little oversight. May lead a project and be responsible for completion.
- May assist with the writing and revising of procedures.
- May be assigned to projects dealing with special samples needing method modifications, with close supervision.
- Records tests results on standardized forms and prepares reports describing procedures used. Prepares charts and graphs to assist in evaluation and interpretation of data.
- Completes investigations into aberrant data and generation of summary reports for their own work, can apply problem solving techniques in a team environment.
- Considered 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 in same.
- Will work with Analysts, Scientists and Management staff on a routine basis for the receipt and preparation of QC Test Samples and Stability study samples.
- Follows good documentation practices.
- Adheres to the Phibro Core Beliefs, demonstrating exemplary behaviors. Identifying EHS hazards and propose solutions to improve lab/safety compliance.
Qualifications
- Analyst III: High School degree or equivalent with approximately 10 years lab experience, preferably in an FDA regulated environment; or 2-year degree with approximately 3 years’ experience or B.S. degree in a related scientific field with approximately 1.5 years of experience.
- Analyst IV: High School degree or equivalent with approximately 15 years lab experience, preferably in an FDA regulated environment; or 2-year degree with approximately 5 years’ experience or B.S. degree in a related scientific field with approximately 3 years of experience.
- Analyst V: High School degree or equivalent with approximately 20 years lab experience, preferably in an FDA regulated environment; or 2-year degree with approximately 10 years’ experience or B.S. degree in a related scientific field with approximately 5 years of experience.
- Technical Skills: Excellent attention to detail; ability to use and perform HPLC, UV, GC and other instrumental techniques; ability to generate protocols and summarize data; ability to communicate within and outside immediate department; may contact vendors and/or external customers for administrative and technical information; ability to work weekends and off shifts, as needed; computer literate with MS Excel, Word; ability to utilize Empower, Trackwise, SAP; familiarity with Lean concepts and 5-S.
Skills
- High degree of time management skills and ability to handle multiple priorities and projects at once.
- Prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
- Excellent Written and Verbal Communication Skills
- Proven ability to work effectively in a team environment.
Education
- Analyst III: High School degree or equivalent with approximately 10 years lab experience, preferably in an FDA regulated environment; or 2-year degree with approximately 3 years’ experience or B.S. degree in a related scientific field with approximately 1.5 years of experience.
- Analyst IV: High School degree or equivalent with approximately 15 years lab experience, preferably in an FDA regulated environment; or 2-year degree with approximately 5 years’ experience or B.S. degree in a related scientific field with approximately 3 years of experience.
- Analyst V: High School degree or equivalent with approximately 20 years lab experience, preferably in an FDA regulated environment; or 2-year degree with approximately 10 years’ experience or B.S. degree in a related scientific field with approximately 5 years of experience.
Additional Requirements
- Physical requirements include operations of laboratory equipment, bending, sitting, standing, talking or hearing, using hands, walking, and vision requirements for focus and distance.