Highlights
Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes. Education: Bachelor's Degree and 4 years of relevant experience, or Associate's Degree and 6 years of relevant experience, or High School Diploma or Equivalent and 8 years of relevant experience.
Numbers & Facts
| Location | Warsaw, IN (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $10–$12.53 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Title: Sr Quality Systems Specialist
Location: Remote--looking for workers in US, Columbia, India
Duration: 12 Months
Duties:
Skills:
Education:
Location: Remote--looking for workers in US, Columbia, India
Duration: 12 Months
Duties:
- Develop and implement processes, procedures, and instruction to sustain and improve the Quality Management System
- Support Top Management in the development and implementation of quality systems strategies and objectives
- Oversee and coordinate the communication and release of corporate documents for all sites
- Develop and support site document control procedures and work instructions
- Develop and execute process improvements to ensure Site Quality processes meet users needs and requirements
- Coordinate project work related to integration of sites and migration to integrated systems.
- Assist and lead audits and assessments, both internal and external, to demonstrate compliance with GMP, ISO, CMDR, and EUMDR regulations
- Support Quality investigations as needed
- Manage and facilitate external standard assessments
- This is not an exhaustive list of duties or functions and might not necessarily comprise all the essential functions.
Skills:
- Excellent working knowledge of current USA Food and Drug Administration (FDA) and global laws, regulations, and standards, particularly EUMDR
- Familiarity with statistical data analysis tools and concepts
- Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship
- Proficiency in technical writing
- Outstanding organizational skills
- Basic experience or knowledge on issue resolution disciplines (e.g. problem solving/decision making, root cause analysis, etc.)
- Must be able to manage stressful situations and to handle controversial issues
- Must be familiar with all aspects and elements of a quality system including but not limited to corrective and preventive action (CAPA), management responsibility, product realization and measurement, analysis and improvement processes
- Highly compliance-oriented to firmly adhere to the principles of the regulations and standards
- High attention to detail
- Demonstrated proficiency with MS Office suite, Adobe Acrobat, PowerBI and various data sources
Education:
- Bachelor's Degree and 4 years of relevant experience, or Associate's Degree and 6 years of relevant experience, or High School Diploma or Equivalent and 8 years of relevant experience
- Bachelor s Degree in life sciences field with minimum 5 years of relevant work experience preferred
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.