11th Shift PQA (Production Quality Assurance)

Production Quality Assurance

Reports To: Production Quality Engineer

Department: Quality Assurance

Location: Jacksonville Manufacturing Facility

Position Summary

Production Quality Assurance works as an independent facilitator and auditor to support and improve the quality system within their production areas, as well as support systems to ensure compliance with the regulatory, company and facility mandates, missions, and goals.

This position reports directly to the Production Quality Engineer. Indirectly, this position provides support to all production teams and engineers in the plastics processing, assembly or finishing production department. This position includes direct authority for the direction of daily floor-related quality activities.

Essential Responsibilities

Production Quality Assurance

1. Attend daily shift War Room meetings.
2. Maintain consistent presence on production floor.
3. Conducts production audits, enters results and works with production on appropriate actions.
4. Facilitates and/or participates in team activities that support quality initiatives.
5. Support the quality department as assigned completing tasks requested by Supervisors and others.
6. Any and all other tasks asked by supervisor to be completed.

Product Release and Disposition

1. Review Finished Goods, Thin Wall and finished goods computer-generated labels for respective areas per current revision of QSP 7.5.5-01 (Label Control).
2. Release of finished goods and interplant transfer components.
3. Disposition activities of non-conforming product according to quality specifications.

Nonconforming Material Control

1. Manage the timely closure of non-conformance reports (ensure NC's are not open more than 30 days).
2. Assists in investigations involving quality as directed by Quality Management.
3. Responsible for maintaining quarantine areas in a timely fashion.

Training and Certification Support

1. Assist in training and conduct testing of protechs in support of the Protech Certification Program.

Documentation and Quality System Support

1. Support quality system elements by ensuring accurate records, complete files, and following procedures to ensure compliance to the quality system.
2. Manage quality record error completion.

Inspection and Protocol Support

1. Provides support for inspection activities including those using a computerized data collection system.
2. Complete and support protocol activities on the production floor.

Systems and Administrative Support

1. Conduct computer work using MS Office applications.
2. Provides support for maintenance of Infinity networks (reset passwords and setup new ProTechs).

Communication and Shift Support

1. Effective Communication to oncoming and outgoing shifts by holding daily communication meetings prior to shift change and updating shift log.

Key Competencies

Knowledge

1. Knowledge of GMPs and plant applications of the quality system.
2. Knowledge of the QA functions for inspection and disposition of product.
3. Knowledge of computer applications including Infinity, Excel, Word, Outlook and SmartSolve.
4. Be able to effectively conduct training including proficiency in Protech Certification.
5. Possess or be able to develop a working knowledge of the Internal Audit process.
6. Math and reading ability at grade level 10 or equivalent.
7. Must have basic understanding of Sampling Techniques and Standards.

Skills and Abilities

1. Good verbal and written communicative skills.
2. Must be able to interact and produce results in a team setting.
3. Have coaching skills to support production and Protech activities.
4. Have leadership skills to deal with exception management and work assignment.

Essential Capabilities

1. Must have visual acuity to perform inspections and label/document reviews.
2. Must be able to physically perform all job tasks that would include walking, standing, lifting, climbing, and bending.

Other Characteristics

1. Ability to work flexible schedule as needed.
2. Ability to work independently with minimal supervision.
3. Good safety record.
4. Ability to embrace and adapt to change.

Minimum Position Requirements for Selection

1. Two - Four years’ experience in the quality systems, procedures, and methods. (Preferably)
2. High School Diploma or GED Required.
3. Experience working in a regulated manufacturing environment preferred.
4. Must have visual acuity to perform inspections and label/document reviews.
5. Physical capability to perform job duties.
6. Math skills to effectively complete job function.
7. Read, work, and communicate effectively in English.