Overview

Position Summary:

Responsible for the technical analysis of raw materials, in-process and finished products, product failures and complaints; support and/or technical support of validations; verification of product claims and dating: and/or provides technical support for formulation and QC testing. Supervises staff as needed.

Responsibilities

Key Accountabilities:

• Coordinates studies which are appropriate for validation, process improvement, product failure or complaint.
• Performs automated and manual processes/assays per organization Standard Operating Procedures (SOP), Standard Production Method (SPM) or Quality Control Monographs (QCM)
• Develops and recommends revisions and improvements to production and quality system documentation.
• Participates in project teams as directed.
• Responsible for coordinating and performing preventive maintenance, troubleshooting, cleanliness and calibration of laboratory equipment. Ensures that appropriate records are maintained
• Assures as necessary that Statistical Process Control records are maintained
• Prepares Change Orders, Condition for Release, and Incident Reports, etc. as required
• Sets a personal example of behavior and commitment to company values and plant objectives to encourage a high level of morale and teamwork for all employees
• Identify department training needs and implement appropriate training measures; mentor and train staff to enhance both individual and department performance.
• Performs all work within organization according to organizational policies, GMP, and ISO Standards
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions

Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Functional/technical skills
• Understanding of Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP)
• Demonstrated ability to organize work assignments
• Knowledge of laboratory equipment/QC instruments
• Proficiency in common laboratory techniques
• Oral and written communication skills
• Business acumen, timely decision making

Qualifications

Minimum Knowledge & Experience Required for the Position:

• Requires BS in a Science or Medical Technology or equivalent, plus minimum four years of experience of clinical laboratory or formulation.
• Supervisory experience preferred.

Travel Requirements: 

• <5% of time