Quality Assurance Compliance Specialist VaxInnate
Quality Assurance Compliance Specialist is responsible for conducting routine reviews and audits of documents and data to ensure compliance with Standard Operating Procedures (SOPs), protocols, and applicable regulations, including current Good Manufacturing Practices, Good Laboratory Practices and other GxP requirements. Review and approve development, production and analytical documentation accompanying the release of bulk production or clinical supply lots to ensure conformance to appropriate regulatory requirements.
Primary Job Duties Include:
Review executed batch production records ensuring compliance with approved procedures and GMP expectations.
Review release test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards and approval of Certificate of Analysis (COA) for lot release
Review of GMP controlled documents such master batch production records, test methods, specifications and managing implementation of required changes to meet GMP and internal standards.
Provide QA support for method qualifications including reviewing protocols and reports.
Provide support for resolution of non-conformances, deviations and other investigations
Ensure the control, distribution and maintenance of internal data and records.
Maintain VaxInnate Master Index Files with respect to batch production records, release/stability data and method qualification data.
Provide guidance in the development and review of VaxInnate Quality Documents.
Write and review Standard Operating Procedures.
Other duties as assigned.
B.S. degree in Chemistry, Biology, or related field with minimum 5 years experience in Quality Assurance or related area preferably within the Biotech/Pharmaceutical Industry
Previous data auditing and batch record/batch release experience required
Thorough knowledge and experience with GxPs, FDA guidance, ICH , industry standards, includingICH and FDA guidance
Strong attention to detail and excellent verbal and written communication skills.
||Three Cedar Brook Drive |
Cranbury, NJ 08512