Summary:
The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process, and final products. In addition, will also develop and validate analytical methods.
Essential Duties & Responsibilities:
· Perform analytical testing in support of product development and method validation.
· Conduct laboratory tests in compliance with established internal Standard Test Methods (STMs), compendial and vendor/partner supplied methods.
· Maintain organized records of tests performed and results obtained by following company policies.
· Perform basic troubleshooting and preventative maintenance of laboratory equipment.
· Understand and comply with all company policies, safety procedures, and SOPS, including cGMPs and cGLPs.
· Assist in the preparation of analytical data for internal and external meetings and presentations.
· Assist in performing laboratory investigations. Contribute to written investigation reports as required.
· Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
· Participate in the transfer of methods to/from the Quality Control department.
Requirements:
· 3 years minimum of pharmaceutical experience required (will not consider someone right out of school, need the experience)
· Minimal lifting required. May need to move boxes, always others around to assist. No more than 20lbs.
· Familiarity with cGMP's, and work experience following cGMP's required.
· Basic skills in using typical laboratory and processing equipment - HPLC required
· Basic understanding of the chemical and physical principles upon which formulation, process development and analytical methodology is based.
· Familiarity with concept of cGMPs.
· Basic skills in using typical laboratory and processing equipment (e.g. HPLC (required), UV Spec, pH meter, centrifuge, etc.).
· Ability to utilize scientific information resources within the assigned area of responsibility.
· Good observation, problem solving, and troubleshooting skills (e.g. rational progression of investigation).
· Good understanding of the scientific thinking in the design of experimental protocols.
· Basic documentation skills (e.g. notebook, reports) with attention to detail and legible handwriting.
· Good organizational skills (e.g. daily tasks, documentation, archived information).
· Good interpersonal skills (e.g. working with members of other teams to achieve shared goals).
· Good verbal and written English communication skills (e.g. able to participate in scientific discussions and written interactions).
· Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).
· Ability to be flexible in adapting work plan to current corporate goals.
· Basic time management skills (e.g. multi-tasking and task prioritization).
Education:
Bachelor's degree in relevant field of study (e.g. chemistry, pharmacy, biology, engineering, etc.) from an accredited college or university required.
Schedule: Monday - Friday, 8:00 AM to 4:30 PM