Quality Assurance Specialist
6 days ago
We are a family-owned contract manufacturer based in Philadelphia, PA, with over 90 years of experience.
Our expertise lies in manufacturing pharmaceutical, nutritional, and cosmetic products for both human and veterinary use.
We prioritize our employees and clients, ensuring exceptional experiences and attracting a diverse range of customers, from start-ups to Fortune 20 companies worldwide.
Choose us for quality, reliability, and innovation.
Do you want to work with a company who are helping people around the world?
- Meaningful Work
- Competitive Compensation Package ($55,000 - $65,000 per year)
- Complete Benefits Package
- Accelerated Career Growth
- Fun Company Activities
- Many More
EDUCATION/EXPERIENCE REQUIREMENTS:
- Minimum 3 years of quality control or quality assurance experience
- BS or BA Biology, Chemistry, Biochemistry, or relevant related field, or sufficient technical/professional experience
- Experience in quality systems including validation, documentation, and compliance
- HPLC analytical experience is a plus
DUTIES/RESPONSIBILITIES:
- Gather and review data from chemists in accordance with internal Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
- Develop specifications for raw materials, finished products, and stability studies.
- Draft analytical procedures, method validation protocols, stability protocols, and expiration memos.
- Prepare Certificates of Analysis (COA) and Certificates of Conformance (COC).
- Represent the Quality department in meetings, providing input and recommendations as needed.
- Ensure compliance with all safety protocols. Familiarity with GMPs, ICH guidelines, FDA regulations, and other relevant regulatory requirements is preferred.
- Initiate action or deviation reports for any identified nonconformances.
- Conduct testing of raw materials, finished products, and additional samples as required.
- Perform other duties as assigned by management.
This is an onsite position (no hybrid or remote flexibility). We offer a competitive compensation package, complete benefits package, accelerated career growth, and fun company activities.
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