Senior Quality Engineer

Responsible for product quality through proper design and implementation of appropriate procedures and specifications, as well as finished goods quality.

Essential Duties and Responsibilities

• Authors, executes and reports on qualification/validations in the following areas:
  • Equipment Qualifications
  • Facility Qualifications
  • Software Validation
  • Computer System Validation
  • Test Method Validations
  • Stability Program Studies
  • Human Factors
• Supports new product development teams to assure product quality is achieved through proper design, testing, and Engineering and Quality specifications
• Assists in risk management program, assesses FMEA updates and controls
• Reviews/develops engineering test/qualification protocols, where required, to assure product/design changes are properly validated prior to release
• Supports process validation activities.
• Communicates and carries Quality Engineering philosophy to other internal groups
• Assures compliance to documentation procedures
• Reviews change requests
• Performs process capability analysis and assists in design of experiment activities
• Interfaces with Product and R&D Engineering groups on design and specification-related issues as well as for approvals, as required.
• Works closely with Quality System personnel to assure compliance with quality system requirements.
• Performs other duties and responsibilities, as required

 

• Bachelor’s Degree in technical field and minimum 2 years related experience for Quality Engineer or 4 years for Sr. Quality Engineer; Master’s Degree Preferred
• Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.
• Test Method Validations
• Stability Program Studies
• ASQ Certification preferred.
• Knowledge of quality engineering principles.
• Ability to analyze component and final product processes to improve overall efficiency and quality..
• Thorough knowledge of GMP, CFR, and factors impacting compliance.
• Knowledge of and ability to utilize statistic in evaluation of data.
• Thorough knowledge of FDA regulations
• Experience with laboratory environment, equipment, and safety procedures.
• Commitment to excellence and high standards
• Excellent verbal and written communications skills in English
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Acute attention to detail
• Demonstrated ability to plan and organize projects
• Ability to work independently and as member of various teams and committees
• Proven ability to handle multiple projects and meet deadlines
• Ability to develop clear, concise, and timely oral and written reports.

Supervisory Responsibilities

• N/A

Competencies

• Analytical--Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Problem Solving--Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics
• Change Management—Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
• Quality Management--Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

Physical Demands and Work Environment

• Ability to lift/move up to 50 pounds