Johnson & Johnson Innovative Medicine · 1 day ago
Quality Assurance Specialist
Athens, GA
Full-time
Onsite
Entry, Mid Level
2+ years expJohnson & Johnson Innovative Medicine is a leader in healthcare innovation, focused on developing treatments and cures for complex diseases. The Quality Assurance Specialist will ensure compliance in all cGMP API Manufacturing Facilities, providing quality and technical feedback, reviewing batch records, and supporting continuous improvement efforts.
Pharmaceuticals
Responsibilities
Batch Record Review/Auditing: Ensures accuracy and compliance of manufacturing records. Verifying data integrity, identifying discrepancies and ensuring adherence to Good Manufacturing Practices. Identifying and resolving discrepancies. Organization and storage of batch records and related documentation, potentially in both physical and electronic formats. Release batch records in electronic systems according to global, local customer, and regulatory requirements. Interface with various electronic databases/systems to interpret data pertinent for release to specific countries. Provide support on local and Global Change Control-related items such as providing input on the proposed change control assessor and implementation activities
Compliance Monitoring: Support and help sustain an environment of continuous improvement. Act as Quality representative to provide on the floor QA oversight and on-call quality support in Manufacturing Operation and escalate issues to quality management for consultation. Identifying and recommending processes to detect errors and reduce rework. Introducing processes to improve product/service quality and customer satisfaction. Monitoring activities, processes, and standards to fulfill the quality requirements for manufacture, testing packaging and storage of materials, components and products. Interacts and partner with other JSC functions related to products manufactured at the site and coordinate strategies for compliance management within the manufacturing areas and Quality Control Laboratories
Nonconformance Support: Receive, document, and investigate nonconformance events or deviations from established procedures or processes. Participate in Root Cause Analysis (RCA) to determine the underlying causes of nonconformances
Ensure GMP Compliance: Participate in internal and external audits to ensure compliance with quality assurance standards. Stay informed of industry trends, regulatory changes, and advancements in quality management practices. Assists in regulatory inspections. Support follow-ups to assure appropriate closure of any outstanding GMP issues from internal and external audits. Escalate compliance issues to the Quality Assurance and Quality Systems Managers. Successfully completes regulatory and job training requirements. Comply with all safety rules, policies, and procedures with the intent to maintain a safe working environment. Report all safety incidents, accidents, or injuries to the supervisor immediately. Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures
Qualification
Required
High School Diploma or equivalent GED
2 years of related work experience in a Good Manufacturing Practices (GMP) regulated environment
Quality Assurance Experience
Ability to demonstrate accuracy and independent judgment with little oversight
Thorough understanding of Quality Systems Regulations, cGMP/GLP regulations, ICHQ7, and FDA requirements
Proven ability to use software applications for data entry, data analysis, word processing, presentation and calculations
Ability to perform under stress in cases of emergency, critical or hazardous situations
Must be able to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities
Ability to apply risk management philosophy to business processes, decisions, and data
Negotiates and resolves conflicts effectively
FDA Regulatory Requirements
Good Manufacturing Practices (GMP)
Quality Assurance (QA)
Quality System Regulation (QSR)
Preferred
Ability to work independently on routine tasks with support to resolve some complex technical issues
Ability to manage and maintain a large volume of records and documentation
A high degree of accuracy and attention to detail
Strong verbal and writing skills, with the ability to convey complex information clearly
Ability to influence & collaborate with all levels of employees
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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