Qualification & Validation Senior Specialist

Quva • Bethlehem Township, NJ

1d • $65,023 - $89,406 • Onsite

About The Position

Our Qualification and Validation Senior Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include driving compliance at a high level with Qualification and Validation policies, procedures, and controls across all QuVa sites that ensure that quality and performance of products, processes, equipment, and facilities conform to established standards, specifications, and regulatory guidelines. The role is responsible for application, qualification, and validation of processes, equipment, control schemes, process optimization and qualification of alternate parts, across all QuVa sites. Activities include startup, demonstration, commissioning, qualification, and validation plans for the entire operations lifecycle. This position will support all facilities activities, equipment onboarding and utilization, and operations, including process improvements and troubleshooting. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Associate’s/Bachelor’s degree or equivalent validation experience
• 5 years’ Qualification and Validation experience including writing and executing protocols, and commissioning documents
• 5 years of pharmaceutical experience including knowledge of cGMP, GDP, FDA Aseptic Guidelines, ISO-14644, and other pharmaceutical regulatory requirements
• Experience in performing smoke studies
• Knowledge of Computer Software Validation (CSV)
• Extensive knowledge of Laminar Flow Hoods, Biologicals Safety Cabinets, Room Classification & Control, Environmental Monitoring, Controlled Environment Testing, calibration of gauges and device, Aseptic Processing Simulation studies, temperature/humidity mapping & monitoring, and air handling unit operation
• Proficient with Microsoft Word and Excel
• Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas

Nice To Haves

• Effectively and productively engages with others and establishes trust, credibility, and confidence with others
• Listens to internal and external customers, ensuring commitments are met, and sets appropriate internal and external customer expectations
• Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform

Responsibilities

• Provides prospective evaluation, technical input, authoring, and review of qualification and validation master plans, commissioning documents, protocol content and execution strategy, ensuring compliance with corporate and regulatory standards
• Provides technical support and guidance on equipment, facilities, and utilities qualification by authoring and reviewing protocols, identifying gaps, and establishing action plans for those items considered critical to meet the local requirements for qualification
• Provides technical support and guidance on process qualification and validation by authoring and reviewing protocols, identifying gaps, and establishing action plans for those items considered critical to meet the local requirements for process qualification and validation
• Provides direct support for the execution process of qualification and validation protocols.
• Supports site inspections from regulatory bodies, providing comprehensive technical background and history related to qualification and validation efforts
• Writes and executes technical documents such as IQ’s, OQ’s, PQ’s, Engineering Studies, Summary Reports, Etc.
• Writes, evaluates, and resolves deviations that occur during protocol execution
• Independently leads higher level projects related to qualification/validation activities across sites to ensure proper and timely completion
• Reviews and approves protocol templates, executes protocols, and summary reports to ensure all appropriate criteria and test cases are captured and met to be compliant with industry standards, mfg. specs and QuVa requirements
• Leads execution and provides training when applicable across sites for smoke study activities including making sure these studies capture the process and aseptic technique correctly
• Assists or leads in creating/writing Standard Operating Procedures (SOPs), Work Instructions (Wis), and Incident Reports (IR’s) for equipment and procedures related to qualification/validation activities
• Supports the proper continuous functionality of qualified/validated equipment and processes supporting the automation/facilities team when complicated issues occur
• Onboarding of equipment to include evaluating the equipment criticality
• Assists in Computer Software Validation (CSV) periodic reviews, gap assessments, and validation activities when required
• Provides training in validation and qualification concepts to all personnel involved with the execution of qualification and validation activities
• Participates in high level troubleshooting activities related to equipment and processes
• Complies with 503B guidelines, ISO standards, Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and company policies
• Conducts investigations, root cause analyses, and develops corrective actions for non-conformances experienced during the execution of qualification and validation activities
• Provides routine communications to internal and/or external stakeholders regarding the status of qualification and validation activities
• As necessary, works with third-party service providers and contractors to ensure overall work is being done in accordance with work instructions, 503B, cGMP, GDP, training, etc.
• Provides guidance, advice, feedback and support to more junior level validation specialists
• Provides technical support and guidance on Deviations, Standard Operating Procedures (SOPs), Work Instructions (WIs), Incident Reports (IRs) related to quality
• Creates status reports and schedules for intradepartmental activities

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree