Job summary:

Responsible for validations and equipment, facility, and system (EFS) qualifications. Ensure the annual requalification and validations described in the VMP are scheduled and performed on time. This is done by working with internal staff to ensure all barriers with regards to validations are identified and removed. Develop and managing relationships with lab staff through continual communication.

Apply industry knowledge in quality review of documents. Share job expertise by mentoring and training staff on validation instrumentation and processes.

Responsible for reviewing control charts for trends as scheduled. Review non-routine repairs for potential revalidation. Assess new equipment for qualification.

Education and experience requirements:

• Analytical Chemistry and Quality Engineering experience strongly preferred
• A.A./A.S. and six years of applicable experience OR B.S./B.A. with at least three years of applicable experience AND any two of the following:
  • M.S.
  • NRCM or NLM (Nelson Labs microbiologist program)
  • ASQ certifications
  • Sterilization Specialist certification
  • Master Trainer certification

Essential job functions:

Validations

• Write, execute protocols, and document test results in accordance with current standards.
• Determine and collaborate on appropriate methods to interpret data
• Compile raw data and final report into completed binder
• Monitor and coordinate efforts to ensure VMP is maintained on time
  • Review work load and coordinate strategies to utilize resources to meet on time schedule.
  • Act as project owner or assign validation/qualifications to team members
• Interface with auditors in discussion of validations

Quality Control

• Control Charting
• Review of non-routine repairs
• Assess new equipment for qualification

Training

• Mentor validation staff
• Teach validation classes and prepare validation training courses
• Cross train in other QC-Validation team functions
• Cross train in use of lab equipment as necessary

Regulatory Compliance

• Know and follow current applicable regulatory requirements (GMP, GLP, ISO, etc).
• Know and follow company policies and procedures
• Write and review quality documents

Professional Development

• Complete required training in a timely manner (includes MasterControl, live company trainings, New Employee Orientation, etc.)

Perform other duties as assigned.

Job requirements:

• Attention to detail
• Ability to follow written instructions
• Must have verbal and written communication skills
• Legible handwriting
• Customer service skills
• Project management skills
• Advanced math skills required.
• Must be able to multi-task and be self-motivated
• Time management- must be able to respond to voicemails, emails and other communications in a timely manner.
• Computer skills: knowledge of Microsoft Office, email and internet usage.
• Communication skills: good verbal communication a must, proficiency in writing techniques a plus.
• Ability to work independently

Physical requirements:

Must be able to spend 70% of the day sitting at a desk on a computer and 30% of the day standing or walking around the lab. Must be able to occasionally lift a minimum of 30 lbs.