Job Description: Role Summary:
Supports the *** Sanford, NC, Quality Operations department by performing Quality Assurance activities including suppler qualification and management, and enrollment of new materials and suppliers associated with clinical and/or commercial products. In addition, may support regulatory agency inspections.
Role Responsibilities:
Individual Accountabilities:
• Perform QA assessments and approvals for supplier management.
• Contributes to the interpretation of cGXPs for the commercial and clinical environment.
• Able to resolve complex issues with minimal assistance from management.
• QA supplier management activities (supplier reassessments, quality agreements, audit reviews, risk assessments)
• QA support and approval for qualification of new suppliers and materials
Shared Accountabilities:
• Support external agency audits
• Develops ability to train other team members on tasks
• Identify and implement new processes and programs for quality improvement.
• Interfaces with other parts of the organization such as *** research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
• Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.
Education or Equivalent:
BA or MS in a science/related field or equivalent education and/or pharmaceutical work experience.
Technical Competencies:
Knowledge in cGXP, materials, components, and supplier management.
Behavioral Competencies:
• Demonstrates business acumen
• Change agile
• Seizes accountability
• Holds people accountable
• Self-Awareness
• Creative thinker
Organizational Relationships:
Reports into the Manager, QA Supplier Management. Interacts with the Sanford QA Supplier Management team, Global Procurement, Site Supply Chain, Technical Operations, Production, other *** Sanford departments and other *** PGS sites. Will also interact with 3rd party suppliers and service providers.
Resources Managed:
• Continuous improvement of processes
• No direct reports
Hard Skills:
1. GMP Systems
2. MS Office
3. Critical thinking/problem solving
Preferred Skills:
1. Team Player (Diverse Team)
2. Positive Attitude
Interview Process:
Panel Teams (Camera-On)
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)
- 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.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time
