Scope of Function:
- To ensure compliance with regulatory and corporate requirements, responsible for reviewing Quality Control documents and records, including, but not limited to, qualification, validation and stability protocols and reports, analytical/test reports, standard operating procedures (SOP), instrument/equipment records, certificates of analysis/testing and periodic summary reports.
- Responsible for quality control analytical data review to ensure compliance with Good Documentation Practices (GDP) and data verification requirements per 21CFR210/211.
- Responsible for administering the training program within the Quality Control department.
- 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, CAP A, and Change Control Reports, to ensure compliance with regulatory and corporate requirements.
Reports To: Quality Control Analytical, Senior Manager or higher
- 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.
- Ensure QC documents are developed in accordance with domestic and international regulatory requirements and corporate standards.
- Author/prepare test procedures, SOPs, protocols, reports and other documents as assigned .
- Ensure analytical data collection per 21 CFR Part 11 compliance, execute data analysis, and verify data integrity.
- Oversee the administration of the QC training program and assist in the execution of regulatory compliant QC employee training, including but not limited to Good Documentation practices, Laboratory Control process and Data Integrity as required,
- Develop and implement codified procedures for result/report receiving, review and recording
- Assist in Client/Regulatory audit responses are addressed on-time .
- Establish and implement self-inspection program for the Quality Control laboratory .
- Ensure QC equipment and instruments are maintained in accordance with established qualification and calibration criteria and schedules.
- Monitor laboratory notebooks to ensure issuance, review, and archival are conducted in a timely manner in accordance with established standards.
- Conduct analytical testing and other duties, as assigned.
Education & Experience:
- Bachelors in biological or biochemical sciences or related field.
- Must have at least three years of direct work experience in FDA regulated environment.
Other Skills and Abilities:
- The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
- Excellent written and verbal communication skills with the ability to effectively promote intra-and inter- departmental cooperation.
- Knowledge of GMP, ICH and compendia! requirements and their application.
- Possess strong character with self-confidence and integrity.
- Experience working within vertically-integrated and virtually-structured settings for small- to mid-sized organizations is preferred.