Come Be Part of a Mission that Matters!

The selected candidate will be responsible for performing instrument/method troubleshooting as well as validation, qualification, calibration, and preventative maintenance, and performing investigations on out-of-specification results, method transfer and method qualifications of new and existing products. The selected candidate will be responsible for training other chemists on analytical methods, instruments, SOPs, and documentation and will participate in QA functions of the QCU including document review, room and equipment log review, room cleaning approvals, and other quality functions as assigned by the Sr. Quality Manager.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

· Completes routine analytical testing of samples supporting incoming raw materials, in-process production, finished product, and validation. Use analytical instrumentation such as FTIR, HPLC, UV/VIS, Karl Fischer, viscometer, and dissolution apparatus

· Performs instrument/method troubleshooting within analytical method parameters and management guidance

· Performs investigations on out-of-specification and out-of-trend results

· Performs instrument validation, qualification, calibration and preventative maintenance

· Participates in method transfer and method qualifications of new and existing products

· Participates in cleaning method validations and analytical method qualifications for cleaning and other validation projects

· Maintains the data archives and samples

· Trains technicians and other chemists on analytical methods, instruments, SOP’s and documentation

· Logs and tracks samples

· Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements

· Writes, reviews and updates standard operating procedures

· Compiles data to support trending program

· Orders chemicals and laboratory supplies as needed

· Possesses the ability to identify, analyze, and work towards correcting potential hazards

· Maintains strictest standards of hygiene in laboratory area

· Performs/facilitates quality audits on procedures, as well as on documents being used to perform these procedures

· Participates in QA functions of the QCU including document review, label approval, room and equipment log review, room cleaning approvals, and other quality functions as assigned by the Senior Quality Manager

· Documents all changes in the change control system

· Selects samples for tests at specified stages in production process, and tests samples for variety of qualities such as performance specifications and chemical characteristics

· Oversees and executes sampling plans and stability plans for current products and development projects

· Participates in quality management system requirements including following departmental work instructions, creating records, document control and addressing corrective and preventative actions

· Maintains retention storage of all product/product components and reagents

· Sets up and performs studies on materials, components, or products to measure performance, shelf life, or product characteristics

· Participates in technology transfer of new products from R&D or OEM

· Participates in efforts to control costs

· Follows safety procedures and company policies

JOB REQUIREMENTS/QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The individual must possess a clear understanding of the performance of various products, how to trouble-shoot problems and must be able to work independently to complete projects and reports. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE: Bachelor’s degree (B.S.) from four-year college or university and two to three years related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS: Ability to read, analyze, and interpret technical procedures and data. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from management, and co-workers.

MATHEMATICAL AND COMPUTER SKILLS: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to work with computer programs such as Word Perfect, Excel, Word, Windows, and other software.