US Tech Solutions · 1 day ago
Quality Assurance Specialist III
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. They are seeking a Quality Assurance Specialist III to support the Client Research and Development quality agreement process, focusing on process improvements and compliance with regulatory standards.
Information Technology
Responsibilities
Provide an active role within R&D as an expert in GCP requirements. The strategic focus is for early detection and prevention, followed by correction of issues
Collaborate with GCP functional areas and assist in the resolution of external partner quality issues
Lead or participate in technically complex and strategic cross functional GCP projects
Lead or participate in GCP focused strategic initiatives to improve compliance with regulatory requirements and standards
Lead or participate in process improvements, including review / update current supporting processes and procedures
Achieve a difficult balance of involvement, independence, and objectivity
May support Clinical Quality Agreement creation and periodic review
Consistently demonstrate Client’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality
Qualification
Required
Minimum of 7 years' total combined experience required (Not necessarily the sum of the above)
Persuasive, effective communication skills are essential with an ability to work effectively across functions, across technical areas, and outside of the company
Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment
Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices)
Provide an active role within R&D as an expert in GCP requirements
Collaborate with GCP functional areas and assist in the resolution of external partner quality issues
Lead or participate in technically complex and strategic cross functional GCP projects
Lead or participate in GCP focused strategic initiatives to improve compliance with regulatory requirements and standards
Lead or participate in process improvements, including review / update current supporting processes and procedures
Achieve a difficult balance of involvement, independence, and objectivity
May support Clinical Quality Agreement creation and periodic review
Consistently demonstrate Client's Ways of Working and Leadership Attributes including a collaborative mindset and leadership
Preferred
Bachelor's degree preferable in a physical science, life science, pharmacy, business, engineering or equivalent experience required
5-7 years of experience in Quality Assurance / Regulatory Affairs (Pharmaceutical or Medical Device preferred)
3-5 years of experience in clinical research and development or manufacturing, or analysis of investigational products
Must have experience with quality agreements and knowledge of worldwide regulatory requirements that influence their content
Accreditation by a professional body is desirable, e.g., American Society for Quality (ASQ) Certified Quality Manager (CQM), Registered Quality Assurance Professional (RQAP), and/or Certified Quality Auditor (CQA)
Company
US Tech Solutions
US Tech Solutions counted among the largest yet the fastest growing staffing firm; all achieved organically.
H1B Sponsorship
US Tech Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (9)
2023 (13)
2022 (24)
2021 (18)
2020 (14)
Funding
Current Stage
Late StageRecent News
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