Planet Pharma · 1 day ago
Quality Assurance Specialist
North Chicago, IL
Contract
Onsite
Senior Level
7+ years expPlanet Pharma is focused on enhancing quality assurance processes in research and development. The Quality Assurance Specialist will lead and support cross-functional projects aimed at improving compliance with regulatory requirements and enhancing process efficiency.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Michael Sullivan
Responsibilities
Primarily responsible for supporting the Research and Development quality agreement process with a focus on identifying and implementing process improvements
Lead or participate in technically complex and strategic cross-functional projects, demonstrating the ability to work across various teams
Drive or support strategic initiatives aimed at improving compliance with regulatory requirements and standards
Take a proactive role in process improvements, which includes the review and update of current supporting processes and procedures to enhance efficiency and effectiveness
Achieve a difficult balance of involvement, independence, and objectivity
Provide support for periodic review of Quality Agreements, ensuring alignment with organizational and regulatory expectations
Collect, analyze, and report relevant metrics to inform decision-making and track the effectiveness of initiatives
Consistently demonstrate 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
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
Minimum of 7 years' total combined experience required (Not necessarily the sum of the above)
Must have experience with quality agreements and knowledge of worldwide regulatory requirements that influence their content
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)
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma 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
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase