Quality Assurance Technician Winter Haven, FL

Job Description

Quality Assurance Technician - Winter Haven FL

MAIN FUNCTION:
The Quality Assurance Technician will support the implementation and enforcement of the Quality and Food Safety Management System requirements throughout all of the manufacturing process in order to ensure compliance with company policies FDA cGMP and industry standards.

KEY SKILLS & COMPETENCIES:
Adaptability

Adapts well to changes in assignments and priorities; adapts behavior or work methods in response to new information changing conditions or unexpected obstacles; approaches change positively and adjusts behaviors accordingly

Building Trust

Interact with others in a way that gives them confidence in ones motives and representations and those of the organization. Is seen as direct and truthful; keeps confidences promises and commitments.

Collaboration

Builds constructive working relationships with clients/customers other work units community organizations and others to meet mutual goals and objectives.

Behaves professionally and supportively when working with individuals from a variety of ethnic social and educational backgrounds.

Continuous Learning and Professional Development

Is committed to developing professionally attends professional conferences focuses on best practices values cutting-edge practices and approaches; takes advantage of a variety of learning activities introduces newly gained knowledge and skills on the job.

Influence

Uses appropriate interpersonal skills and techniques to gain acceptance for ideas or solutions. Uses influencing strategies to gain genuine agreements;

Seeks to persuade rather than force solutions or impose decisions or regulations.

Planning and Organizing

Organizes work sets priorities and determines resources requirements; determines necessary sequence of activities needed to achieve goals.

Quality Orientation

Monitors and checks work to meet quality standards; demonstrates a high level of care and thoroughness; checks work to ensure completeness and accuracy.

Safety Awareness
Being aware of conditions and circumstances that affect ones own safety or the safety of direct reports.

Teamwork

Participates as an active and contributing member of a team to achieve team goals. Works cooperatively with other team members involves others shares information as appropriate and shares credit for team accomplishments.

Technical/Professional Knowledge and Skills

Possesses acquires and maintains the technical/professional expertise required to do the job effectively and to create client/customer solutions.
Technical/professional expertise is demonstrated through problem solving applying professional judgment and competent performance.
DESCRIPTION OF WORK PERFORMED:
Perform Risk Based Quality Layered Audits based on:

First Pass Quality Deviation Rejections
EMP testing and related GMP practices
Customer complaints (cap seal / torque box seals labels leaking containers)
Foreign material risks (Glass plastic wood gasket material etc.)
Weight compliance
Formulation Compliance (staging order of addition etc.)
Calibration Compliance (Torque wrenches scales etc.)
Weight Verification and Label compliance
Validation of CCPs and OPRPs
GMP Allergen G&BP program audits
Job cycle check
Supports QC Manager in Cross Functional Initiatives

Audit for implementation and sustainment of CAPAs
Provide interface with operators during MOC validations
Monitoring of GMPs during MOC Construction etc.
EMP swabbing and tracking
FS&Q Skills Validation support to operations
Escalate issues to QC Manager
CIP tank cleaning swab/cleaning verification and validation
Labeling compliance
Container Compliance
GMP support
GMP Inspections
Daily GMP Walkthrough
Weekly/Monthly Glass and Brittle Plastics Inspections
Other tasks as assigned by the Quality Control Manager
Schedule is 8am-5pm M-F. Schedule may include additional time as needed and approved by management.