- Audits batch records to ensure compliance with policies, procedures and regulations.
- Ensures batch records are complete and accurate, with all NC's dispositioned prior to release.
- Identifies, records and reports on batch non- conformances and product holds.
- Stores and maintains batch files either physically or electronically based on established guidelines.
- Applies principles of Good Documentation Practices.
- Executes assigned NR actions within the applicable software application.
- Provides metrics and updates on executions.
- Maintains training records up-to-date.
- Perform document change management as required per local procedures.
- Use of computer-based applications to manage:
- Inventories,
- Batch records
- Down time
- Communication
- Inventory equipment
- Education:
- High School/Secondary Education or Equivalent.
- Required Qualifications:
- Quality-oriented mindset
- Flexibility
- Team environment; collaboration
- Service Oriented
- Excellent written, oral communication, organization and computer skills required.
- Preferred Qualifications:
- Medical Device experience preferred.
Quality Technician - Warsaw, United States - Cygnus Professionals Inc.
Description
Role: Quality Technician
Location: Warsaw IN (Need Local candidates only)
Job Type: Contract
Number of positions: Multiple
Job Description:
SECTION 1: JOB SUMMARY
·Responsible for conducting technical quality assurance inspections and using results to improve production processes and standards.
SECTION 2: DUTIES & RESPONSIBILITIES
Batch Release and Records Management
General Responsibilities
·The following must be included for all positions:
o Responsible for communicating business related issues or opportunities to next management level.
o 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
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
o Performs other duties assigned as needed.
SECTION 3: EXPERIENCE AND EDUCATION
o High School.
o Generally, Requires 0-2 Years Work Experience.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS