Validation Specialist II

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, as well as developing and managing relationships with lab staff through continual communication. Mentor staff and perform basic training on validated instrumentation and processes. Review non-routine repairs for potential revalidation. Assess new equipment for qualification. Assign open expiry for incoming chemicals, reagents, and assist with the quality assessment of incoming supplies.

Essential Duties

• Write, execute protocols, and document test results in accordance with current standards.
• Compile raw data and final report into completed binder.
• Cook up efforts to ensure VMP is maintained on time.
• Review workload and coordinate strategies to utilize resources to meet on time schedule.
• Act as project owner and collaborate with and across teams to ensure timely completion of assigned projects.
• May travel to complete qualifications at internal or external labs.
• Collaborate with and across teams to resolve complex issues.

Quality Control

• Control Charting as needed.
• Review of non-routine repairs.
• Assess new equipment for qualification.
• Provide quality oversight of new supplies ordering.

Training

• Mentor and train staff as appropriate.
• Cross train in other QC-Validation team functions.
• Cross train in use of lab equipment as necessary.

Professional Development

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

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Complete required training on time.

Professionalism

• Attend work regularly and reliably.
• Adhere to all policies and procedures.
• Perform other duties as assigned.

Competencies

• 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.

Work Environment

• This job operates in a professional office and laboratory environment.
• This role routinely uses standard office equipment such as computers, keyboards, computer mouse, telephones, photocopiers, projectors and file cabinets.
• Occasional travel during the business day.
• Some out-of-the area and overnight travel may be expected.
• May be required to attend trade shows, seminars and conferences in addition to sales travel.

Physical Requirements

• Must be able to stand/walk for 30% of the day and 70% of the day sitting at a desk or on the computer.
• Must be able to occasionally lift a maximum of 45lbs.

Education And Experience Requirements

• A.A./A.S. and four years of applicable experience OR
• B.S./B.A with at least two years of applicable Experience AND
• Any One Of The Following:
• M.S.
• A.SQ certifications
• Master Trainer certification