Quality Assurance Manager

4 weeks ago


King of Prussia, Pennsylvania, United States Beacon Hill Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Manager to join our team at Beacon Hill. The successful candidate will be responsible for providing oversight, leadership, and management support to QA and QC operations.

Key Responsibilities:


• Manage a team of QA Specialists and QC Analysts to ensure the quality of manufactured products.


• Track Bulk Drug Substance record review and disposition lifecycle to ensure compliance with regulatory standards.


• Direct employees by assigning and maintaining timelines for product disposition, ensuring timely completion of tasks.


• Review Quality Control testing data against established specifications to ensure accuracy and reliability.


• Review and approve Protocols and General Technical Reports to ensure compliance with regulatory requirements.


• Review and approve Disruption to Controlled Environment (DCE) data compilation to ensure accuracy and reliability.


• Review and approve Raw Material Specification (RMS) revisions to ensure compliance with regulatory standards.


• Approve Change Controls to ensure compliance with regulatory requirements.


• Raise critical quality issues to upper management to ensure prompt resolution.


• Write and revise Quality Systems SOPs as necessary to maintain compliance with regulatory standards.


• Assist in hosting regulatory inspections to ensure compliance with regulatory requirements.


• Monitor Quality Control programs and procedures to ensure compliance with compendial standards.


• Verify associated Quality documentation, as needed, to ensure accuracy and reliability.


• Provide training and development opportunities to employees to enhance their skills and knowledge.

Requirements:


• Bachelor of Science degree in a scientific discipline.


• Minimum five years of Quality experience in the biologics or pharmaceutical industry.


• Excellent knowledge of CGMP guidelines, 21 CFR Parts 210 and 211, and other regulatory standards.


• Writing experience in a similar role in the biologics or pharmaceutical industry.


• Experience in aseptic processing and/or mammalian cell culture production considered a plus.


• Flexibility and ability to adjust to changing priorities and unforeseen events using excellent time management skills.


• Ability to execute multiple tasks with a high degree of accuracy and detail.


• Positive work attitude that supports teamwork and continuous improvement.



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