Quality Control Validation Specialist

POSITION

The QC Method Validation Specialist leads project tasks and activities associated with analytical method qualification, validation, and verification. Specific activities include preparation, execution and review of protocols and reports associated with analytical method development, qualification and validation. You will be responsible for participating in laboratories' readiness for routine testing of clinical phase GMP products, H/UPLC Purity Method development and validation. This role reports to the Director of Production.

General Responsibilities

• Leads project with minimal supervision, manage project timelines and deliverables.
• Drives continuous improvement; represent QC (analytical H/UPLC purity method development and validation) on cross functional teams; and providing guidance and training to other team members; troubleshooting.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
• Coordinates action plans and contributes toward team and project goals.
• Interacts with clients, presents data to clients as group representative, independently on occasion and with minimal supervision.
• Review and authorize all laboratory data and have extensive overall knowledge of all laboratory operations.
• Create, review, and approve compliant test method development and validation protocols and reports.
• Implement statistical tools, root cause analysis methodologies, etc.
• Train and assist team members. Create an environment knowledge-sharing so everyone on the team learns and grows with the Company.
• Produce and maintain good written documentation of experiments.
• Participate actively in joined projects.
• Ensure implementation, compliance, and continuous improvement of QMS through SOP documentation.
• Other duties as assigned by Management.

Job Requirements

• BS or BA degree in science or related field required.
• At minimum 2-3 years of experience in quality in the biotech or pharmaceutical, or highly regulatory industry required.
• Experience in purity determination by RP-HPLC Analytical method validation is required.
• Able to lift, push, and pull up to 40 pounds.
• Experience in laboratory practices, comprehensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories and working experience with a wide range of analytical techniques, analytical testing and use of analytical equipment required.

Compensation: Base salary range: $90,000–$100,000 annually, depending on qualifications and experience, plus benefits.

Pay: $90,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Work Location: In person