Job Overview
About the Position
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