Qa Specialist II- Validation

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

The QA Specialist II – Validation is a member of the Quality Assurance department and partners with other members of the QA, Operations, QC and Validation organization to work and perform an array of defined QA validation activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. The QA Specialist assists with internal and external project teams on validation/qualification projects, process and equipment validation, and system initiatives to ensure on time deliverables are met. The incumbent is expected to exercise greater initiative in executing job duties as well as train and assist less experienced team members.

Requirements

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.
Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards
Deeply experienced in providing oversight in implementing and maintaining GMP equipment, processes and computer systems in a validated state
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

Nice To Haves

ASQ certification preferred
Demonstrates ability to perform detail-oriented work with a high degree of accuracy
Ability to make risk based decisions and resolve issues with minimal guidance
Excellent verbal, written and interpersonal communication skills
Effective time management and interpersonal skills.
Strong organizational skills, planning skills and must work effectively within teams
Well versed and proficient with all Microsoft tools in particular Word, Excel, Outlook and PPT
Ability to work in a dynamic, fast paced work environment
Honesty, integrity, respect and courtesy with all colleagues
Creative with the ability to work with minimal supervision and balanced with independent thinking
Resilient through operational and organizational change
Validation experience with the following is preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization. Steam Sterilization

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.