QA Regulatory & Compliance Specialist

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

The QA Regulatory & Compliance Specialist is responsible for the adherence of company policies and procedures, especially regulatory and ethical standards as governed by state, local, federal and international pharmaceutical regulatory agencies. This position ensures that products meet all relevant quality standards and regulations before release into the marketplace and actively monitors all regulatory trends and emerging requirements as well as potential risks. The QA Regulatory Compliance Specialist also compiles data and assists with preparation of Annual Product Reviews and Annual Reports according to Quality Assurance procedures and pharmaceutical regulations for management approval. He / She supports QC Laboratories and Technical Services in reviewing and interpreting cGMP information with attention to detail and accuracy. This individual supports management and peers in improving the effiency and compliance status of the plant and laboratories through cross collaboration.

ROLES & RESPONSIBILITIES :

• Coordinate and participates in quality audits of other departments within the organization for compliance with cGMPs and company policies and procedures. Also participates in self inspection of Quality unit for same purpose.
• Supports the QC laboratories and Technical Services in compliance with cGMP standards, registered details, and product specifications and release criteria.
• Prepares preliminary documentation (i.e., technical writing) for investigations, SOPs, change controls, CAPAs, regulatory submission content, and other Quality Assurance related documentation, etc. for final review and approval.
• Completes periodic Standard Operating Procedure (SOP) reviews for Quality unit and notifies management of any SOPs that may require revision and initiates change requests per written policy, providing sufficient evidence (documentation) to support change request(s).
• Responsible for issuance and maintenance of cGMP procedures to include cGMP documentation maintenance, storage, and archival process as well as daily activities to support process, including check out / check in of cGMP records.
• Performs Batch record review and release for product distribution.
• Supports preparation of Annual Product Review and Annual Reports.
• Utilizing advanced knowledge of FDA regulations and principles, compiles trending quality data reports for management review.
• Investigates root cause(s) and develops appropriate Corrective and Preventive Actions (CAPAs) for plant incidents, and monitors CAPAs life-cycle through completion. Also responsible for record retention.
• Responsible for guiding other departments with Change Controls, Corrective and Preventive Actions (CAPA), Master Batch Record (MBRs) review, and other Chemistry, Manufacturing and Control (CMC) changes.
• Responsible for full-cycle Product Complaint process and initiates steps required to close these investigations. Ensures that required testing and due dates are completed, preparing final complaint report summary and obtaining final approval by head of department.
• Under the direction of the department director, identifies and implements quality system improvements, including training programs and assisting site with FDA preparedness activities.
• Completes ongoing daily inspection readiness activities by appropriate decision making and documentation and by exhibiting a quality culture escalating any concerns that may implicate product quality or potential for non-compliance with regulations and / or procedures.
• Serves as backup for cGMP training responsibilities to ensure awareness of regulations and company policies and procedures (for employees and contractors).
• Keeps abreast of current technical and professional literature and compendia, attending technical discussions, and training opportunities.
• Regularly reviews and evaluates adherence to policies / procedures and regulations for cGMP-related KPIs and metrics, and makes recommendations to department manager for improvements.

Follows and encourages safety first in work practices via guidance from training sessions, chemical hygiene plan, Safety Data Sheets (SDS), and other technical literature and resources.

QUALIFICATIONS - EDUCATION, WORK EXPERIENCE, CERTIFICATIONS :

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES :

EEO Statement

USAntibiotics is an EEO / AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, gender identity and expression, national origin, age, disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.