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Lab Analyst

Willow Island, WV

6 Months

Note: 40 hours Monday-Friday (8 am-5 pm), with possibly occasional weekend coverage

POSITION 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 client Standards.

• Conducts laboratory activities related to experiments, studies, and projects in support of production, laboratory, or other client groups:

o Understands and follows cGMP regulations.

o Data maintenance and record keeping are in accord with GMP and SOPs

o 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 client Core Beliefs, demonstrating exemplary behaviors. Identifying EHS hazards and propose solutions to improve lab/safety compliance.

EDUCATION AND EXPERIENCE:

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 REQUIREMENTS:

• 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 the following applications: MS Excel, Word

• Ability to utilize application software such as: Empower, Trackwise, SAP.

• Familiarity with Lean concepts and 5-S.

PHYSICAL POSITION REQUIREMENTS:

The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the colleague is regularly exposed to laboratory and office settings, and a manufacturing environment. The colleague will be required to utilize certain Personal Protective Equipment, including but not limited to hard hats, safety (“steel-toed”) shoes, eye protection, gloves, and protective clothing. The colleague must be able to access all areas of the plant.