Quality Assurance Specialist

Johnson & Johnson • Athens, GA

1d • Onsite

About The Position

Johnson and Johnson Innovative Medicine is recruiting for a Quality Assurance Specialist to be located in Athens, Georgia. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine This position is responsible for ensuring compliance in all cGMP API Manufacturing Facilities at the J&J Innovative Medicine, Athens Georgia site. This includes, but is not limited to, providing quality, compliance, and technical feedback/ regarding quality and manufacturing activities, batch record review and approval, and Quality Assurance on the floor ensuring adherence to company policies while contributing to continuous improvement efforts.

Requirements

• 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.

Nice To Haves

• Associate's degree in a Science, Engineering, or other technical discipline is 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees