Specific Duties, Activities, and Responsibilities:
Routine Auditing and Compliance: Perform regular audits of the manufacturing facility to ensure compliance with cGMP, DEA, FDA, and local site procedures.
QA Support for Manufacturing: Provide QA support for clinical and commercial batches, ensuring GMP compliance in production activities.
Line Clearances & Inspections: Conduct line clearances, equipment releases, AQL inspections, and in-process checks as defined by quality procedures.
QA Logbook Management: Execute, review, approve, and maintain QA department logbooks, including but not limited to QA HOLD, Rejection, and PBR trackers.
Audit Raw Materials and Facility Logs: Conduct audits of raw materials, warehouse, and facility logs to ensure proper documentation and compliance.
Review and Approval of Records: Review and approve Cleaning Batch Records (CBR), Production Batch Records (PBR), and Master Batch Records (MBR).
Audit Participation: Participate in regulatory, customer, and internal audits to ensure compliance with industry standards and regulatory requirements.
Quality Systems Management: Assist with the quality review and closure of various quality system records, including deviations, complaints, change controls, and OOS/OOT investigations.
SOP Creation and Revision: Create, revise, and approve site Standard Operating Procedures (SOPs) to ensure compliance with current industry standards and regulatory requirements.
Non-Conformance Investigation: Act as a QA representative in non-conformance investigations, ensuring proper documentation and root cause analysis.
Quality System Approval: Support site quality review and approval of quality systems record closures, including deviations, change controls, and complaints.
Document Review and Approval: Review and approve critical documents from the analytical department, such as CoAs, stability reports, method validations, protocols, and micro reports.
Retain Sample Inspections: Perform annual retain sample inspections to ensure sample integrity and compliance with regulatory requirements.
Batch Disposition Decisions: Make final approval/rejection decisions on batch disposition, ensuring compliance with quality standards and regulatory requirements.
Raw Material Approval: Review, approve, and release raw materials for manufacturing processes, ensuring compliance with quality specifications.
Cross-Departmental Communication: Facilitate interdepartmental communication to obtain necessary information and resolve issues efficiently.
Quality Event and Batch Investigations: Assist with the investigation and resolution of quality events and batch-related issues.
Shift Flexibility: Willing to work flexible shifts and rotational weekend work to support manufacturing operations, including extended hours as required.
Position Requirements:
Education and Experience:
Minimum Bachelor's degree or equivalent in a related field with 3+ years of relevant experience in Quality Assurance, Compliance, or Manufacturing within the pharmaceutical industry. Thorough understanding of compliance, regulations, and inspection techniques, including cGMP. Demonstrated ability to evaluate facility records, processes, procedures, and practices to ensure conformance to industry regulations.
Knowledge/Skills:
Strong knowledge of FDA, cGMP, and DEA regulations pertaining to pharmaceutical development and manufacturing.
Familiarity with SDS requirements and the ability to understand safety procedures related to hazardous materials and chemicals.
Knowledge of document control procedures and their application within the Quality Assurance function.