Description - Internal
JOB TITLE: Quality Cell Leader (QA FINAL)
Leads the QA and DL Operators to assure that product complies with the quality standards.
• Preparing Rework Protocols or memos for NCRs.
• Evaluating NCR.
• Investigating NCR.
• Approving NCR.
• Completing NCR.
• Evaluating SU's NCR.
• Investigating SU's for NCR.
• Approving SU's NCR.
• Completing SU's NCR.
• Providing Direction.
• Monitoring Unit Performance.
• People Development.
• Providing Capabilities to Work Unit.
• Assuring Compliance with Laws & Regulations.
•Payroll Administration/ Kronos.
• Vacations & Overtime Administration for Non- Exempt.
• Verifies all equipment is calibrated.
• Supports QAO and DL associates by providing resources, advice, etc.
• Promotes teamwork.
• Creates quality awareness (GMP, procedures).
• Promotes adequate communication within other departments.
KNOWLEDGE, SKILLS AND ABILITIES
• Computer literacy in MS Word, Excel, and Power Point.
• Excellent oral/written communication skills.
• Fully bilingual.
• Service oriented.
• Ability to coordinate, evaluate and inspect.
• Generally works in manufacturing area (loud noise but could be in office area (moderate noise), depending day's work.
• Needs to walk and use hand to finger, handle or feel.
• Performs physical effort with some exposure to extreme cold, wet or humid conditions.
• Utilizes vision and mental attention frequently.
• Works with a personal computer and programs to prepare documents or reports.
• Applies communication skills to perform work and coordinate with others.
• Most of the time he/she stands, walks, and use hands to finger, handle or feel.
• Utilizes a high analytical capacity and high level of professionalism and judgment to resolve Problems.
• Bachelor degree in Business Administration, Industrial Engineering or Science.
• QSR certification.
• Non Hazardous Waste Management certificates.
Minimum of five years on experience in a medical device/ pharmaceutical industry in a similar position.