Business Analyst

Description

Description Specific Responsibilities and skills and skills for position
Perform routine manufacturing data entry/gathering, analysis, and trending to determine statistical significance, and evaluate process variation and capability using statistical techniques and control charts.
Support lead engineers in preparing presentations and documents for manufacturing reviews on a regular basis.
Prepares required engineering and manufacturing documentation, for revision and approval by management.
With guidance, performs routine tasks to aid technical investigations and assessment of deviations, particularly as related to data generation/gathering and analysis.
Prepares required engineering and manufacturing documentation, for revision and approval by manager/supervisor.
Supports the preparation of documents for Regulatory filings.
Works on assigned projects through completion with limited direct supervision.
Performs assigned activities on projects related to scaleup, validation, and technology transfer between sites.
May assist with aspects for the specification, installation, utilization, qualification, and improvement of equipment used for solid dose and liquid products.
May assist with equipment/process qualification (IQ/OQ/PQ) and validation (PV)
May assist with drafting qualification/validation/technical protocols and reports.
Knowledge, Experience and Skills
BS degree in a science field, preferably in an engineering field or a related technical discipline.
1 5 years of relevant industry experience with BS or BA
Some knowledge/experience on statistical techniques including process capability, control charts, etc. is preferred.
Basic knowledge/experience on manufacturing solid oral dosage and/or sterile injectables is a plus.
Good verbal, written, and interpersonal communication skills are required.
Normally receives limited instructions on routine work and general instructions on new assignments.
Works on problems of a routine to basic scope where analysis of data requires evaluation of identifiable factors.
Working knowledge of typical computer applications.
Basic knowledge of Good Manufacturing Practices (GMPs).