Qa Specialist II- Validation

Position Title

QA Specialist II – Validation

Location

Bedford, New Hampshire

Department

Quality Assurance

Reporting To

QA Manager/QA Director

Essential Duties And Responsibilities

• Review and approve Validation plans, User Requirement Specifications (URS), Validation protocols and summary reports, associated with the commissioning and validation of equipment and utilities, cleaning validation, process validation and method validations without supervision.
• Work in partnership with other QA and Validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, and project management to achieve all project deliverables, and build strong working relationships.
• Works closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements across all PCI sites.
• Provide QA oversight for GMP validation activities and apply risk based methodology to validation efforts.
• Provide QA assessment and approval of GMP validated systems related procedures, deviations, CAPAs and change controls with no supervision depending on complexity of system.
• Provides guidance/mentoring to junior members of QA team on less complex issues.
• Participate in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs.
• May support cGMP manufacturing operations as needed with review of batch records and supporting documentation (Deviations, Investigations, Environmental Monitoring, and Sterilization records).
• Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practice.

Qualifications

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5+ years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production.
• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
• Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
• Validation experience with the following is preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Steam Sterilization.
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Strong working knowledge in validation methodology, software development life cycle principles and Part 11 Compliance.
• Keen understanding of international quality systems regulations to adopt best in class systems/ processes and drive continuous improvement initiatives.
• Preferred ASQ certification preferred.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Exhibits excellent verbal, written and interpersonal communication skills.
• Displays effective time management and interpersonal skills.
• Shows strong organizational skills, planning skills and works effectively within teams.
• Profound proficiency with all Microsoft tools in particular Word, Excel, Outlook and PPT.
• Capable of working in a dynamic, fast-paced work environment.
• Displays honesty, integrity, respect and courtesy with all colleagues.
• Displays creative thinking with the ability to work with minimal supervision and balanced with independent thinking.
• Displays resilience through operational and organizational change.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.