Planet Pharma · 11 hours ago
Quality Assurance (QA) Specialist III
North Chicago, IL
Full-time
Onsite
Senior Level
$30/hr - $40/hr
7+ years expPlanet Pharma is a company focused on the pharmaceutical industry, and they are seeking a Quality Assurance (QA) Specialist III. The role involves supporting the Research and Development quality agreement process and leading strategic initiatives to improve compliance with regulatory requirements.
BiotechnologyHealth CarePharmaceutical
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 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)
Experience Level = 5-7 Years
Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries
Thorough understanding of international GCP regulatory standards
Must have a technical background and extensive knowledge of worldwide requirements for quality systems
Preferred
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
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