USA

Obtains pertinent information via various communiqués concerning medically related product information requests, and enters that information into the validated computer database.

Accurately responds to queries from health care professionals and consumers as instructed during training in utilizing written and verbal Standard Response Letters and other approved resources.

Manages execution of medium scale projects related to technology solutions and long-term functional business requirements:

Demonstrates special skills and knowledge into a particular research project as evidenced by proven success at the bench. Demonstrates a high level of initiative in performing experiments, particularly when problems are encountered which require troubleshooting.

Provides timely, accurate data analysis support for 71 sheet releases (intermediates, raw materials, API, and related samples from Chemical Development) as necessary.

Basic Qualifications

College degree in animal science, biological science, or other related field required; or an equivalent combination of education and relevant experience.

Prefer MS or other advanced degree in a biological science.

AALAS certification at LATG level required if coming from a laboratory animal background (applicable only to positions involving in vivo work).

Provide Technical Leadership responsibilities as well as project management; with broad industry perspective, provides technology direction and process improvement.

Job Responsibilities

Understand the principles involved in ongoing experiments. Learn and utilize all appropriate experimental design methods needed for pharmaceutical industry work in area of specialization.

Demonstrate a high level of initiative in performing experiments, particularly when problems are encountered which require troubleshooting.

RESPONSIBILITIES
• Perform assigned batch record reviews and review of other records relating to the processing of components, materials and finished veterinary biologicals for comparison with approved specifications and regulatory requirements.

Reviews batch records (MFRs, MBRs, QBRs) and gives disposition (approval, rejection, etc.) to the lot or material produced to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met and the raw materials and solutions have been tested and released.

Basic Qualifications

BS with a minimum of 8 years or MS with a minimum 6 years in QA/QC positions of increasing breadth of responsibility in the pharmaceutical or biotechnology GMP regulated industries. Degree in biology, chemistry, engineering, or other related scientific disciplines are preferred