Quality Release Technician

Johnson & Johnson•Cornelia, GA

5d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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

Responsibilities

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.
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.
Performs other duties assigned as needed