Quality Control Lab Supervisor - Med Device

Job Description

Job Description

Summary of Essential Duties and Responsibilities

• The Quality Control (QC) Laboratory Supervisor position supervises and coordinates activities of team members engaged in inspecting incoming materials, in-process components, and finished products to ensure adherence to company quality standards and customer specifications.
• The QC Lab Supervisor plans the daily work of this team to ensure completion of all testing, including raw materials, in-process, final release, stability, and special project / protocol testing in a timely manner that achieves fulfillment to commitments for internal and external customers.
• Coordinate as needed with external contract laboratories for routine product testing, test method development, and method qualification
• Ensure, as necessary, methods are validated per appropriate stage of Design Control. This will include review of existing methods to verify currency of technique and validation status.
• Responsibilities include hands-on performance of analytical testing assignments as part of the total analytical resource availability
• When non-conforming materials, components or products are found, the position is responsible for laboratory investigations as needed to facilitate the processing of non-conforming results in a timely manner. The Laboratory supervisor may represent the team in non-conforming material disposition meetings.
• Execute and coordinate stability testing of polymer devices and combination drug products.
• Develop knowledge of requirements (commercial, Regulatory, cGMP, GDP, GLP, ISO-, etc.) specific for REVA processes and products and adapt to the quality control and development programs as appropriate.
• Manage the calibration, preventative maintenance, and qualification activities related to the analytical equipment
• Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards.
• Interact with inspectors in regulatory audits to represent area of responsibility and lead laboratory audit ready status efforts.
• Ensure employees are properly trained and / or qualified and that training records are current. Drive cross training for efficiency.
• Lead and build QC team, make hiring decisions based on effective interviews. Hold regular meetings with the team to provide performance appraisals, drive accountability and feedback. Ensure employees have development plans

Perform other duties as assigned.

Education and / or Experience

Required Knowledge / Skills

Effective presentation / communication skills, prioritization and resource management skills.

Ability to simultaneously train and lead others, work independently and in a team environment.

Frequent computer / report work, and administration of quality system programs and resources.

Ability to prioritize and stay focused on assignments

Physical Demands / Working Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit or stand for prolonged periods of time, frequently in front of a computer.