Quality Specialist

Shift: 1st shiftM-F standard business hours
Duration: 12 months
Pay range:$45.00 Hourly
Onsite Job
Job Description:

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: Bachelors 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:
At LanceSoft full time regular employees who work a minimum of 30 hours a week or more are entitled to the following 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.

Required Experience:

IC