Ecocareers ยท 3 days ago
CQA Engineer
North Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expConfidential company is seeking a CQA Engineer to play an active role within R&D as an expert in GCP requirements. The role involves leading GCP projects, collaborating with functional areas to resolve quality issues, and improving compliance with regulatory standards.
Staffing & Recruiting
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
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
Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills and sound judgment
Persuasive, effective communication skills are essential with an ability to work effectively across GCP functions, across technical areas and outside of the company
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
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase