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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
**Job Function: **
Quality
**Job Sub Function: **
Quality Control
Job Category:
Business Enablement/Support
All Job Posting Locations:
Cornelia, Georgia, United States of America
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Entry support individual contributor that executes tasks, following a defined standard output or set of procedures. Provides support for internal teams in the Manufacturing Assembly area. Closely follows established administrative processes to ensure accuracy, timeliness, and quality of deliverables. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.
Responsible for set up, troubleshooting and operation of Ethicon Strip Polish Machinery for Ethicon Cornelia site under the direction of the manufacturing facilitators. Responsible for adhering to all quality and Safety requirements.
Entry to developing individual contributor, who works under close supervision. Contributes to the processes and activities related to fulfilling the Quality Assurance requirements for the organization's products. Develops close partnerships with customers and key stakeholders. Uses data to identify risks and improvement opportunities. Implements risk mitigations and process improvements through continuous improvement projects with support. Escalates issues and risks as required. Supports data review and metrics reporting. . Responsible for using data to determine reliability and conformance of quality control process. Accountable for identifying trends and reoccurring issues and suggesting solutions. Administer and coordinate document control and quality record keeping activities to ensure compliance with regulatory and business requirements.
SECTION 2: DUTIES & RESPONSIBILITIES*
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Applies developing knowledge of Quality Control standards to review results of quality analysis and report issues as required.
Supports data review and analysis, and leads implementation of risk mitigations and continuous improvement initiatives under supervision.
Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
This job does not require any experience. This job is overtime eligible.
Collects and compiles data on reoccurring product defects.
Reviews raw material inspection logs and escalates consistent failures.
Implements work processes, measurements and performance metrics to identify improvement areas.
Attends meetings with customers, suppliers and associates to understand standards and expectations.
Supports process improvement teams.
Monitors and scrutinizes internal and external complaints and compiles data to be used in reports.
Gathers and assembles details on defective products and materials.
Review production batch records for compliance with quality system policies and procedures.
Resolve any identified problems
File records
Release finished goods for distribution.
Review records for completeness
Verify that all DMR requirements have been fulfilled
Complete lot release documentation
Tag product approved, as applicable
Maintain and archive quality records.
Keep files organized and secure
Scan records for electronic storage
Work in team environment behaving in a CREDO based respectful manner
Comply with all federally regulated programs.
Adhere to J&J environmental and safety policies and guidelines.
Comply with all job specific safety procedures and utilize PPE when necessary.
Comply with quality system requirements as defined within procedures and instructions.
Utilize applicable software systems as needed for the job (e.g. Compliance Wire, PLM, ERP, MES, etc.)
Consistently meet required work performance targets (RE's), if applicable
Support LEAN and Six Sigma Initiatives.
Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation).
Consistently meet required Training due date targets.
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
*SECTION 3: EXPERIENCE AND EDUCATION **
- Associate degree in science or technology.
- Generally, requires 0-2 Years Work Experience; or equivalent combination of education and experience in an FDA regulated work environment.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Well-organized; attention to detail; handle multiple tasks or priorities; good interpersonal skills.
- Team skills including excellent verbal and written communication and interpersonal relation skills including conflict management.
- Must have demonstrated statistical and analytical problem-solving skills.
- Intermediate or advanced computer and database management skills.
- Must be proficient with all office equipment, copier, scanner
- Knowledge of Operating Procedures and related computer systems required.
SECTION 6: ADDITIONAL POSITION REQUIREMENTS
- Amenable to working within scheduled shifts and assigned work hours
- Open and flexible to render overtime when required
- Willing to work while using Personal Protective Equipment (PPE) as needed
- Capable of meeting physical job requirements, including prolonged standing, sitting, walking, and lifting up to 30 lbs
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.
#LI-Onsite
**Required Skills: **
Preferred Skills:
Accountability, Administrative Support, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Process Oriented, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Teamwork, Technologically Savvy