Quality Assurance Specialist

1 week ago

Reston, Virginia, United States Barrington James Full time

We are seeking an experienced Quality Assurance Reviewer with a strong background in both biologics and small molecules to play a crucial role in ensuring the highest standards of product quality, regulatory compliance, and manufacturing processes.

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

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