Quality Assurance Specialist

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Assurance Specialist

Qualifications

• At least three years of Quality Assurance experience in a GMP-regulated pharmaceutical, biopharmaceutical, biotechnology, or comparable life-sciences environment.
• Direct QA experience with both Change Control and Qualification or Computer System Validation activities.
• Demonstrated experience reviewing and approving Change Control records through implementation verification and closure.
• Demonstrated experience reviewing qualification or CSV lifecycle documents and executed protocols, including discrepancies and summary reports.
• Working knowledge of applicable GMP regulations, Good Documentation Practices (GDP), regulatory guidance, data integrity principles, risk-based qualification and validation, and industry standards relevant to the assigned scope, including FDA cGMP requirements and, as applicable, EU GMP Annex 1, 21 CFR Part 11, and ISPE/GAMP principles.
• Ability to exercise independent QA judgment, document defensible decisions, identify compliance risks, and escalate issues appropriately.
• Experience coordinating cross-functional meetings, tracking actions, and presenting status and risk information to management.
• Strong written and verbal communication skills in English. Spanish proficiency is preferred for effective site interaction.
• Demonstrated ability to prioritize and coordinate multiple Change Control, Qualification, and CSV activities; manage review queues and target dates; and communicate schedule risks, dependencies, and required decisions.

Preferred Qualifications

• Bachelor degree in science, engineering, quality, information systems, or a related discipline, or an equivalent combination of education and relevant experience.
• Experience in aseptic pharmaceutical or biologics manufacturing.
• Experience serving as a Change Control program owner, coordinator, or committee chair.
• Experience with configurable electronic quality management systems and electronic approval workflows.
• Experience with 21 CFR Part 11, GAMP 5 principles, supplier documentation leverage, and risk-based validation.
• Experience preparing executive-level dashboards and presenting quality-system status across an organization.

Scope

General QA Oversight

• Provide independent QA oversight for assigned Change Control, Qualification, and CSV activities.
• Evaluate records for technical and procedural completeness, documented risk, objective evidence, traceability, data integrity, and compliance with approved procedures.
• Review and approve or reject assigned records within delegated authority and document clear, actionable comments when correction is required.
• Identify compliance risks, overdue actions, documentation gaps, conflicting requirements, or conditions that may affect implementation, qualification, validation, or release.
• Escalate significant quality, compliance, schedule, or resource risks promptly to the designated OcyonBio management representative.
• Maintain inspection-ready records and ensure decisions, conditions, open items, and follow-up actions are documented in the applicable controlled system.

Change Control Program Ownership

• Collectively provide QA ownership and day-to-day coordination of the Change Control program during the engagement.
• Review new and active Change Control records, impact assessments, classifications, change plans, implementation evidence, effectiveness checks when applicable, extensions, amendments, cancellations, and closure packages.
• Confirm that affected functions, products, processes, equipment, utilities, computerized systems, documents, training, validation, regulatory considerations, and action items are adequately assessed.
• Verify that required actions and approvals are complete before implementation or closure and that objective evidence supports the recorded disposition.
• Monitor record status, aging, target dates, overdue actions, bottlenecks, and closure readiness through an accurate program tracker or dashboard.
• Coordinate and lead the Change Control Committee, including agenda preparation, record selection, meeting facilitation, documentation of decisions and action items, and follow-up to completion.
• Establish an appropriate meeting cadence with the Company and support ad hoc meetings for urgent or high-risk changes.
• Promote consistent application of the Change Control procedure and provide guidance to initiators, functional area owners, subject matter experts, action owners, and approvers.

Qualification Quality Governance

• Govern qualification decisions from the QA perspective and provide documented rulings or recommendations on system impact, qualification boundaries, required lifecycle deliverables, test strategy, leverage of vendor or commissioning evidence, acceptance criteria, discrepancy disposition, and release readiness.
• Review and approve assigned qualification lifecycle documents, as applicable, including System Level Impact Assessments, User Requirements Specifications, Criticality or Critical Aspects Risk Assessments, Functional and Design Specifications, Validation Plans, Requirements Traceability Matrices, protocols, discrepancy reports, interim reports, and validation or qualification summary reports.
• Confirm that direct-impact systems receive the required qualification coverage and that the rationale for indirect impact or no-impact classification is adequately documented.
• Verify that critical aspects and approved requirements are traceable to suitable test coverage and objective evidence.
• Review protocol readiness before execution, including prerequisites, calibration status, source documents, acceptance criteria, data sheets, and approval status.
• Provide QA oversight during protocol execution as required, review contemporaneous documentation and supporting evidence, assess discrepancies, and determine whether testing may continue, must be suspended, or requires approved retesting.
• Review executed protocols and closure packages and provide the QA decision on successful completion and fitness for intended use within delegated authority.
• Confirm completion of Change Control commitments and required approvals before recommending or granting formal release when authorized by the Company.

Computer System Validation Quality Oversight

• Evaluate, review, and approve all assigned Software Development Life Cycle and CSV lifecycle documents, protocol execution records, closure packages, and supporting evidence for GxP computerized systems.
• Applicable documents may include GxP assessments, User Requirements Specifications, Validation Plans, vendor assessments, electronic data compliance assessments, Functional Specifications, functional risk assessments, design or configuration specifications, IQ OQ and PQ test scripts, discrepancy reports, Requirements Traceability Matrices, Validation Summary Reports, and system release documentation.
• Confirm that the validation approach is commensurate with intended use, system category, risk, configuration, electronic records and signatures, interfaces, data integrity requirements, and supplier involvement.
• Verify that requirements are addressed in specifications and testing, that test scripts are approved before execution, and that executed evidence is complete, attributable, legible, contemporaneous, original, accurate, and traceable.
• Review CSV discrepancies, investigations, impact assessments, corrective actions, and retest evidence and confirm appropriate resolution before closure.
• Evaluate changes to validated computerized systems and confirm that applicable validation and release activities are defined and completed through Change Control.

Procedure Governance

• Review and approve procedures governing the Qualification and Change Control processes within delegated authority.
• Assess proposed procedure changes for consistency with site practices, current templates, related quality systems, approval responsibilities, and applicable regulatory expectations.
• Support drafting or revision of procedures, forms, templates, work instructions, and guidance when requested by the Company.
• Communicate approved procedural changes and support training or implementation activities as assigned.

Status Reporting and Communication

• Provide concise periodic status reports to upper management covering Change Control performance, Qualification and CSV review workload, risks, decisions needed, and forecasted completion.
• Report relevant status and priorities to the QA team through the established QA meeting cadence.
• Present appropriate program updates to the broader organization during periodic company meetings.
• Maintain metrics and dashboards that support timely decisions, including record volume, aging, overdue actions, upcoming target dates, review queues, closure forecast, and significant quality risks.
• Prepare meeting materials and retain decisions and action items in the approved location or system.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.