Laboratory Analyst III

Role Summary

The Laboratory Analyst III is an integral part of the Quality team based out of the US - Willow Island, WV site. The role supports the Medicated Feed Additives (MFA) business and provides testing and release support for the Willow Island manufacturing site. The position may require a 4 - 10 hour rotating daytime shift covering weekends, with overtime based on business needs.

Responsibilities

• Receives and prepares samples for analytical testing and initiation of stability studies.
• Performs physical testing of routine and non-routine samples with minimal supervision, including raw materials, in-process testing, API and finished goods release and stability testing.
• Supports 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 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 per 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 or instrument problems and reports them with input to cause and possible solutions.

Responsibilities Continued

• Performs routine tests and experiments following compendial or standard procedures.
• Applies Lean and 5-S concepts where appropriate.
• Sets up, adjusts and operates laboratory basic equipment (balances, pH meter, sieves, ovens) and uses advanced equipment (Viscosity, Karl Fischer, UV/VIS, HPLC, GC).
• Maintains and follows Standard Operating Procedures; may lead projects and be responsible for completion.
• May assist with writing and revising procedures; may be assigned to projects requiring method modifications with close supervision.
• Records test results on standardized forms and prepares reports; creates charts/graphs to aid evaluation and interpretation of data.
• Completes investigations into aberrant data and generates summary reports; applies problem-solving techniques in a team environment.

Responsibilities Continued

• Acts as Subject Matter Expert in procedures for their area; provides training inside and outside their department.
• Maintains a safe and clean working area and assists others similarly.
• 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 safety/compliance improvements.

Qualifications

• Education and Experience – Analyst III: High School diploma or equivalent with approximately 10 years of lab experience (preferably in an FDA-regulated environment); or 2-year degree with approximately 3 years of experience; or a B.S. degree in a related scientific field with approximately 1.5 years of experience.

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 the immediate department; may contact vendors or external customers for information.
• Ability to work weekends and off shifts, as needed.
• Computer literacy: MS Excel, Word; with ability to use Empower, Trackwise, SAP.
• Familiarity with Lean concepts and 5-S.

Education

• Analyst III: High School diploma 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: (not required for this title but listed for internal equivalence) High School diploma 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: (not required for this title but listed for internal equivalence) High School diploma 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: operations of laboratory equipment; bending, sitting, standing, talking, hearing; manual dexterity; walking; visual acuities including close, depth, distance, and peripheral vision.