Quality Specialist

Quality Specialist – Audits & Inspections

A Quality Specialist – Audits & Inspections is responsible for executing and maintaining the Internal Audit, Client audit and Regulatory inspection programs. The Quality Specialist ensures the site complies to the following guidelines: 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10. The Quality Specialist supports quality compliance through the execution of internal and external audits and ensures inspection readiness for regulatory agency reviews. The Quality Specialist supports cross-functional audits and inspection readiness by coordinating mock inspections and coaching subject matter experts.

Key Responsibilities

• External Audit Preparation & Execution: Support scheduling, hosting, and responding to external client audits.
• Inspection Readiness & Execution: Support mock inspections and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.
• Governance (Metrics & Monitoring): Support monitoring the Audits & Inspections program by tracking, trending, and analyzing data from past audits, inspections, and quality issues to identify systemic risks and drive continuous improvement. Reporting key performance indicators (KPIs) related to audits and inspections and continuously informing senior leadership.
• Deviation & CAPA Management: Monitor deviations, audit Corrective and Preventive Actions (CAPAs), and health authority commitments ensuring responses and actions are completed and submitted on time.
• Effectiveness Checks: Ensure appropriate effectiveness checks are defined and appropriate for assigned audit CAPAs to identify the success of elimination of root causes and prevention of new occurrences.
• Communications: Utilize effective communication channels, tools, and resources to ensure appropriate awareness and participation to support the maintenance and continuous improvement of the audits and inspections program.
• Documentation & Record retention: Ensure critical documentation is appropriately documented and stored to support client audits and regulatory inspections.

Minimal Requirements

• Education: Bachelor's degree in a scientific, engineering, or health-related field.
• Experience: At least 5 years of experience working within the pharmaceutical or medical device industry
• Experience: At least 8 years of experience working in quality within the pharmaceutical or medical device industry in deviation management, pharmaceutical operations, quality assurance, or relevant business areas within the pharmaceutical or healthcare industry.

Skills

• Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10
• Excellent communication and interpersonal skills with the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels
• Strong problem-solving skills with a proven track record in issue resolution
• Proficient in electronic quality management systems such as Documentum, Veeva Vault, and TrackWise
• Strong organizational and time management skills to meet critical business and functional timelines
• Detail oriented with keen eye for identifying process improvement opportunities
• Strong relationship-building skills with the ability to work effectively in team environments across all organizational levels

Employee Benefits

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft

LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.