QA Specialist I

Scope of Function: 

· Responsible for reviewing analytical testing and manufacturing documents and records, including, but not limited to, batch records, specifications, qualifications, validation and stability protocols and reports, analytical/test reports, standard operating procedures (SOP), certificates of analysis/testing and periodic summary reports to support the timely and compliant disposition of products and records.

· Responsible for manufacturing and QC data review of all records to ensure compliance with Good Documentation Practices (GDP) and data verification requirements per 21CFR210/211. 

· Responsible for origination or review of exception documents and records related to Quality Control operations including but not limited to Out of Specification (OOS), Out of Trend (OOT), Deviation, CAPA, and Change Control Reports, to ensure compliance with regulatory and corporate requirements.

The position operates under the established Quality Unit procedures and supervision, with final product disposition authority retained by designate, qualified, and authorized Quality Unit personnel. 

Specific Duties:

• Review executed manufacturing and filling batch records for completeness, contemporaneous documentation, adherence to approved instructions, critical process parameters, calculations, yields, material reconciliation and traceability.
• Ensure quality control analytical data comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Ensure quality control documents and records comply with GMP, GDP and corporate requirements. 
• Ensure that exception documents and records comply with GMP, GDP and corporate requirements, and are closed prior to analytical testing disposition. 
• Review records related to deviations, change controls, OOS, and CAPAs related to Manufacturing and QCA/QCM. 
• Review in-process test results for executed batches and master filling records. 
• Review microbiology test data for release of raw materials, in process materials and final product release.
• Ensure QC documents are developed in accordance with domestic and international regulatory requirements and corporate standards.
• Ensure analytical data collection per 21CFR Part 11 compliance, execute data analysis, and verify data integrity. 
• Assist in Client/Regulatory audits and regulatory inspections.
• Monitor manufacturing and laboratory notebooks to ensure issuance, review, and archival are conducted in a timely manner in accordance with established standards.
• Review applicable environmental monitoring results, excursions, aseptic processing records, interventions and contamination-related investigations for documented assessment of potential product impact.
• Confirm that relevant equipment calibration, maintenance, qualification and cleaning status, and applicable utilities or process      monitoring records, have been addressed in the batch review package.
• Work with manufacturing and quality control to resolve quality events in a compliant and timely manner. 

Education and Experience Required:

· Experience in a biologics CDMO or clinical-phase drug substance and/or sterile drug product manufacturing environment.

· Familiarity with batch disposition packages, aseptic processing, environmental monitoring, OOS/OOT investigations, deviations, CAPAs and change controls.

· Experience with electronic quality management systems (eQMS), laboratory information management systems (LIMS), electronic batch records and audit trail review.

· Excellent written and verbal communication skills with the ability to effectively promote intra-and inter-departmental cooperation.

· High attention to detail

· Knowledge of GMP, ICH and compendial requirements and their application.

Possess strong character with self-confidence and integrity.