Senior Specialist, Quality Control

Title:

Senior Specialist, Quality Control

Description

Location:

Onsite

Status Type:
Full Time

• BS/BA in a Science or related field, or equivalent combination of education, training, and experience
• 6 years of experience in Quality Assurance for the pharmaceutical or medical device industries

• Excellent communication skills. Knowledgeable in implementing and managing Quality Assurance systems and procedures
• SME for at least one quality system where the individual is recognized outside the department as the point person
• Familiar with medical device manufacturing systems and methods. Possess a strong balance of technical experience, analytical thinking, and communication skills for resolving issues internal and external to the organization. Competent with word processing, spreadsheets, and statistical analysis software packages (preferably Word, Excel, and Minitab)
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), and ERP systems such as SAP
• Ability to independently adapt behaviors and strategies to deal with emergent, non-routine and dynamic components of the job
• Quickly adapts to a diverse array of changing needs, conditions, priorities, or opportunities
• Solid ability to understand complexity and navigate ambiguity to influence at the department level
• Plan and carry out multiple projects concurrently
• Ability to analyze problems and troubleshoot solutions
• Apply strong cognitive ability to collecting, processing, and disseminating information
• Understand current state and dynamics of the business
• Ability to foster teamwork, collaboration, negotiation, and influencing others
• Consistently open and approachable
• Engage colleagues and partners with the Enable Values in mind
• Ability to maintain a positive attitude and show empathy for others
• Ability to understand your own emotions and their effects on your performance
• Ability to express your emotions appropriately and have a positive impact on others in support of company goals and a healthy work environment
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Excellent time management skills

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Position requires being physically present on the premises during regular company hours or as approved by management

• Complete equipment validation (IOQ, PQ), ISO 8 clean room qualification and temperature mapping for quality laboratory equipment
• Owns gamma sterilization program including conducting sterilization validations, coordinating quarterly dose audits and general maintenance for addition of new product models to the sterilization cycle
• Quality oversight of equipment validation for cross functional departments, new equipment management and equipment maintenance programs
• General laboratory activities including but not limited to, sample receipt, inventory control, testing, equipment and instrument operation/maintenance
• Performs everyday laboratory requirements which includes cleaning, maintenance, ordering of supplies, and maintains adequate inventory of supplies needed for all microbiological testing
• Schedules and tracks Calibration and Metrology activities