Sr QA Validation Specialist (Oversight)

About the role

Support validation of equipment, utilities, software, cleaning and sterilization processes at our Rensselaer, New York facility in accordance with regulatory requirements by implementing company manufacturing standard policies and procedures. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
• Investigates and troubleshoots problems which occur during validations and determines solutions or recommendations for changes and/or improvements.
• Coordinates with functional departments to resolve issues from validations.
• Reviews, edits and approves deviation notifications, deviation investigations and corrective actions.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Develops tracking mechanisms for validation activity completion for various projects and prepares status reports.
• Presents validation project and program status reports to senior management on a routine basis.
• Ensures that validation status is maintained for equipment and software used in commercial and clinical manufacturing.
• Stays current with industry trends, regulatory requirement updates and communicates them to teams.
• May present at both internal and external (regulatory) audits.

Requirements

• B.S. in life sciences or related field; may substitute proven experience for education requirement.
• QA Validation Specialist: 4+ years of experience.
• Sr. QA Validation Specialist: 6+ years of experience (level will be determined based on experience).

Benefits

• Student loan paydown program & tuition reimbursement.
• Family care benefits.
• Relocation assistance.
• Inclusion, culture and well-being programs (including physical & mental health).
• Competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

Salary Range (annually): $67,400.00 - $128,700.00.

Schedule

Monday-Friday, 8am-4:30pm.

Location: Rensselaer, New York, United States.