Technical Validation Specialist

Position Title: Technical Validation Specialist

Pay Rate: $25.00 DOE (Non-Exempt)

Reports to: Director of Quality

Position Summary:

Oversee the daily operations of the Validation department. Responsible for technical writing, change control, and deviation management for equipment/facility and validation activities related to IQ, OQ, PQ, PV and CV. Ensure that validation protocols, reports and risk assessments are developed using a risk-based approach consistent with ICH Q9 (Quality Risk Management) and completed in a timely manner.

Ensure manufacturing, production and laboratory equipment are maintained in a validated state that meets current cGMP requirements (21 CFR Parts 210 and 211), applicable USP standards, MoCRA requirements for cosmetic products, and customer requirements, and that all validation documentation complies with ALCOA data integrity principles.

Key Duties/Responsibilities:

Tasks/ Responsibilities including but not limited to:

· Provide the highest level of internal and external customer service.

· Draft Validation protocols, reports, risk assessments and technical justifications in accordance with current cGMP, ALCOA data integrity principles, and company SOPs.

· Provide technical and statistical expertise to teams.

· Facilitate implementation of process control systems and statistical process control charts.

· Support facility, equipment, process and cleaning validation activities using a risk-based, lifecycle approach.

· Maintain the site Validation program (facility, equipment, process, cleaning) in a continuous state of compliance and readiness for regulatory and customer audits

· Ensure validation documentation and any associated electronic records/systems comply with ALCOA data integrity principles and, where applicable, 21 CFR Part 11.

· Support audit readiness and assist in responding to observations from FDA, customer and third-party audits related to validation.

· Contribute original ideas to improve work environment.

· Support other areas of QA/QC as needed.

· Provide one-on-one training and mentoring support to Quality department staff, as needed

· Set department goals.

· Comply with and enforce all safety requirements.

· Support all company policies.

· Performs other duties as assigned.

Skills and Abilities:

• Communication Proficiency.
• Learning Orientation.
• Data Integrity & Quality Risk Management (ALCOA , ICH Q9).
• Presentation Skills.
• Time Management.
• Problem Solving/Analysis.
• Customer/Client Focus.
• Teamwork.
• Collaboration.

Education and Experience

• Bachelor’s Degree in Engineering, Life Sciences, Chemistry, or a related field preferred.
• 3 years of related validation/quality experience in cGMP-regulated Consumer, Cosmetic and/or OTC Drug Product manufacturing.

· Working knowledge of current cGMP (21 CFR Parts 210/211), applicable USP standards, ICH Q9 quality risk management principles, and MoCRA requirements as applicable to cosmetic and OTC drug products.

· Familiarity with data integrity principles (ALCOA ) and electronic record-keeping requirements (21 CFR Part 11), where applicable.

· Excellent English written and verbal communication skills.

· Superior problem solving, decision making and organizational skills.

Working Conditions/Job Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Some of the work will be performed in manufacturing facilities where the noise level may be loud.

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.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential job functions.

Pay: From $25.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Vision insurance

Work Location: In person

Salary : $25