Quality Assurance Specialist
Job Title: Quality Assurance Specialist
Company: Biopharma
Location: PA, NJ, NY, MD, DE
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
Position Overview:
As a Quality Assurance Specialist (GMP), you will be responsible for reviewing development commercial batch records, overseeing batch disposition, managing external quality events, and participating in audits and inspections.
Opportunity Highlights:
- Contribute to the review of commercial batch records for API intermediates, API, drug product, and finished product
- Provide assistance in the QA review of documents supporting regulatory submissions, such as CMC sections for INDs to FDA and other regulatory authorities, licensing applications, and periodic updates
- Participate in internal quality improvement initiatives by evaluating processes, suggesting and implementing improvements, and creating or revising relevant SOPs
- Collaborate with the Quality Team, CMC, Regulatory, and Development teams to achieve compliance standards
- Maintain up-to-date knowledge of applicable regulations, guidelines, and company standards and procedures
Position Requirements: Bachelor’s Degree Required, Scientific Discipline
- Minimum of 5+ years of experience within a biotech and/or pharmaceutical manufacturing industry
- Strong knowledge of GXPs, particularly US cGMPs, and a strong understanding of global cGMPs
- Comprehensive knowledge and expertise in the principles and practices of current GMPs from development to commercial applications
- Familiarity with FDA regulations and ICH Guidelines within the biotech and/or pharmaceutical manufacturing environment
- Proficiency in designing, developing, and reviewing CMC QA Standards and procedures
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.
