Jackson Healthcare
QA Regulatory & Compliance Specialist
Jackson Healthcare, Bristol, TN, United States
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:
• BS/BA degree from an accredited institution in Chemistry (or related science) or equivalent related analytical experience.
• Minimum five (5) years of analytical experience in pharmaceutical industry or related technical scientific work experience.
• Knowledge and experience of cGMPs and regulatory documentation.
• SAP experience a plus.• Quality certifications and Operational Excellence experience desired and statistical experience a plus.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
• Demonstrates comprehensive understanding of Title 21 CFR Part 210 and 211 and 314.80 and 81 and applicable compendial requirements and scientific concepts in decision making.
• Knowledge and understanding of pharmaceutical QC analytical techniques and test methodologies, production processes, and reporting for data integrity and compliance with procedures, product registrations, and cGMPs.
• Experience with the concepts and validation methods, processes, equipment, facility, utilities, computerized software.
• Understands documentation required of equipment installation, validation, calibration, batch records, and annual reports, annual product reviews, etc.
• Strong knowledge of cGMPs, USP and FDA's related requirements.
• Strong verbal communication skills and technical writing skills
• Provides technical expertise, risk assessments and solutions related to possible compliance, technical, or safety-related issues and notifying management promptly, suggesting appropriate corrective and preventive action(s) and assisting with implementation.
• Advanced computer skills.
• Ability to prioritize multiple and competing projects and decide appropriate course of actions routinely.
• Ability to work in a cross-functional team environment with a flexible, team-oriented perspective.
• Appropriate interpersonal (teamwork) and leadership skills.
• Self-motivated and able to execute decisions timely and effectively
• Demonstrates visual acuity per SOP requirements.
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.
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:
• BS/BA degree from an accredited institution in Chemistry (or related science) or equivalent related analytical experience.
• Minimum five (5) years of analytical experience in pharmaceutical industry or related technical scientific work experience.
• Knowledge and experience of cGMPs and regulatory documentation.
• SAP experience a plus.• Quality certifications and Operational Excellence experience desired and statistical experience a plus.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
• Demonstrates comprehensive understanding of Title 21 CFR Part 210 and 211 and 314.80 and 81 and applicable compendial requirements and scientific concepts in decision making.
• Knowledge and understanding of pharmaceutical QC analytical techniques and test methodologies, production processes, and reporting for data integrity and compliance with procedures, product registrations, and cGMPs.
• Experience with the concepts and validation methods, processes, equipment, facility, utilities, computerized software.
• Understands documentation required of equipment installation, validation, calibration, batch records, and annual reports, annual product reviews, etc.
• Strong knowledge of cGMPs, USP and FDA's related requirements.
• Strong verbal communication skills and technical writing skills
• Provides technical expertise, risk assessments and solutions related to possible compliance, technical, or safety-related issues and notifying management promptly, suggesting appropriate corrective and preventive action(s) and assisting with implementation.
• Advanced computer skills.
• Ability to prioritize multiple and competing projects and decide appropriate course of actions routinely.
• Ability to work in a cross-functional team environment with a flexible, team-oriented perspective.
• Appropriate interpersonal (teamwork) and leadership skills.
• Self-motivated and able to execute decisions timely and effectively
• Demonstrates visual acuity per SOP requirements.
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.