QA Specialist, Validation

About the role

The QA Specialist, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning.

Responsibilities

• Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program.
• Affirms the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment.
• Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Makes manufacturing (clean room) shop floor support for issue resolution, as needed.
• Participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.
• Maintains flexibility to support 24/7 manufacturing facility.
• Performs other duties, as assigned.

Requirements

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Excellent oral and written communications skills and fluency in English.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Ability to think critically and have superior problem-solving skills.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.

Preferred Qualifications

• Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software.
• Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
• Understanding of Drug Substance, Drug Product and/or Finished Goods manufacturing processes.
• Experience with startup projects or initiatives.
• Training and/or familiarity with Quality Risk Management principles.

Physical Requirements

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 120 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.