At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Athens, Georgia, United States of America
Job Description:
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.
Key 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.
Qualifications
Education:
- High School Diploma or equivalent GED
- Associate's degree in a Science, Engineering, or other technical discipline is preferred
Experience and Skills:
Required:
- 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.
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
Other:
- While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, hear and reach with hands and arms.
- The employee may occasionally lift and/or move up to 10 pounds.
- Up to 10% travel may be required
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
FDA Regulatory Requirements, Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality System Regulation (QSR)
Preferred Skills:
