We are seeking an experienced Quality Assurance Reviewer with a strong background in both biologics and small molecules to join our team. The successful candidate will play a crucial role in ensuring the highest standards of product quality, regulatory compliance, and manufacturing processes. You will collaborate with cross-functional teams to review batch records, deviations, CAPAs, and other quality documentation to maintain compliance with current Good Manufacturing Practices (cGMP). This is an exciting opportunity to apply your expertise to help ensure the safety and efficacy of products in development and production.
Key Responsibilities:
- Review batch production records, quality control data, and associated documentation for biologics and small molecule products to ensure compliance with cGMP, regulatory requirements, and internal standards.
- Evaluate deviation reports, investigations, and corrective/preventive action (CAPA) plans to confirm thorough root cause analysis and implementation of effective solutions.
- Collaborate with manufacturing, quality control, and regulatory teams to resolve quality issues and discrepancies in production records.
- Support product release by ensuring all quality documentation is complete, accurate, and meets applicable regulatory requirements.
- Conduct quality audits of internal and external processes, including suppliers and contract manufacturers, to ensure compliance with industry standards.
- Assist in regulatory inspections and customer audits, providing necessary documentation and responding to inquiries related to product quality and processes.
- Review and approve standard operating procedures (SOPs), protocols, and validation documents to ensure alignment with cGMP requirements and company quality standards.
- Participate in risk assessments and continuous improvement initiatives to enhance product quality and reduce compliance risks.
- Ensure proper documentation and control of quality records in accordance with company policies and regulatory guidelines.
Qualifications:
- Bachelor's degree in Chemistry, Biology, Biochemistry, or a related scientific discipline. Advanced degree preferred.
- Minimum of 3-5 years of experience in a quality assurance role within the pharmaceutical or biotechnology industry, specifically involving both biologics and small molecules.
- Comprehensive understanding of cGMP, ICH guidelines, FDA/EMA regulations, and other relevant regulatory frameworks.
- Proven experience reviewing batch records, deviations, and CAPAs for biologics and small molecules.
- Strong attention to detail, with excellent analytical and problem-solving skills.
- Effective communication skills, both written and verbal, to collaborate with cross-functional teams and external partners.
- Experience with electronic quality management systems (eQMS) and document control systems is a plus.
- Ability to manage multiple tasks and priorities in a fast-paced environment while maintaining high-quality standards.
Preferred Skills:
- Experience with Quality Risk Management (QRM) and root cause analysis.
- Familiarity with the production processes for biologics (e.g., cell culture, fermentation) and small molecules (e.g., chemical synthesis).
- Knowledge of process validation and analytical method validation.
- Familiarity with audit procedures and regulatory submission processes.
Contract Details:
- 12 Month length
- Please note that we can’t provide H1B sponsorship for this role