Quality Assurance Specialist

Planet Pharma; Holly Springs (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading pharmaceutical company in Holly Springs, North Carolina, seeks a QA specialist to provide quality support and oversight for commissioning, qualification, and Computer Systems Validation. The role involves managing QA oversight of various automation platforms, collaborating with DTI teams, and ensuring compliance with manufacturing regulations. Ideal candidates will possess relevant degrees and a strong background in quality assurance with experience in CSV and automation support.

Qualifications

• Experience in quality assurance with a focus on commissioning and qualification.
• Proven ability to manage relationships with vendors and partners.
• Familiarity with Good Manufacturing Practices and regulatory compliance.

Responsibilities

• Provide QA oversight of commissioning and qualification activities.
• Collaborate with DTI on automation platform projects.
• Review and approve qualification protocols and reports.
• Manage DTI platform activities and system administration.

Skills

Quality assurance oversight

Computer Systems Validation (CSV)

Automation support

Risk management

Education

Doctorate degree

Master's degree and 3 years of experience

Bachelor's degree and 5 years of experience

Associate degree and 10 years of experience

High school diploma / GED and 12 years of experience

Job description

This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem and ongoing Automation support to the Manufacturing floor and expansion projects.

• Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV).
• Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
• Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution.
• Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
• Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
• Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
• May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders.
• Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
• Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
• Participate in meetings related to document planning, execution, and issue resolution.
• Escalate any compliance concerns or critical gaps to QA management.
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience