Nice-Pak/PDI

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Quality Assurance Supervisor

at Nice-Pak/PDI

Posted: 10/5/2019
Job Reference #: *FB367B4BA42D0F4B
Keywords:

Job Description

Requisition Number
19-0231

Post Date
10/2/2019

Title
Quality Assurance Supervisor

City
Mooresville

State
IN

Description

POSITION PURPOSE

This position is primarily responsible for assuring that released raw materials and finished goods have met the required specification criteria prior to release, and to maintain accurate, complete and traceable documentation related to analysis and disposition. Provide Quality leadership to compliance initiatives for the implementation of statistical process control in packaging and compounding. In addition, this position will support continuous development of an FDA / OTC and ISO-compliant quality system that conforms to the Nice-Pak Quality Manual. The Quality Assurance Supervisor interacts with Compounding, Production, Research & Development, Customer Service, Purchasing Dept., Training Coordinators, Warehouse, and the New York and UK facilities to help facilitate the development, implementation, enhancement, and training for all Quality Systems and Process Improvement programs.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

  1. Supervise Quality Assurance personnel in Line Audits, Raw Material inspection and incoming Finished good verification.
  2. Ensure that documented evidence is provided demonstrating that product meets release criteria.
  3. Ensure that safety and hazard practices are understood and followed.
  4. Provide support of quality systems in the following areas:
    1. Identification and traceability of components and finished goods.
    2. Equipment and Process Change Control
    3. Support Quality Planning and Continuous Improvement
    4. Ensure compatibility between process capability and Finished Product specifications
    5. Provide leadership in the identification of and justification for capital needs and improvements in the Indiana facility.
    6. Support Indiana Vendor Qualification and Supplier Audit programs.
    7. Assure Nice-Pak Indiana documentation and records are maintained and archived in accordance with GLP’s, FDA, and established Nice-Pak standards by auditing.
    8. Support measurement and reporting of Non- Quality Costs.
    9. Ensure that reporting personnel are trained and qualified to do his/her job by selection, training

      and evaluation of performance.

    10. Support selection and implementation of Quality Management (Data) Systems and Statistical Process Control Systems for the Indiana facilities.
    11. Assist as required in training of plant personnel.
    12. All other duties as assigned.

    13. The above is intended to describe the general content of and requirements for the performance job this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements.



    Requirements

    QUALIFICATIONS

    EDUCATION/CERTIFICATION:

    • Bachelor’s degree in Engineering, Science or Mathematics, or equivalent experience.

    REQUIRED KNOWLEDGE:

    • Strong analytical skills and ability to systematically approach problems and develop solutions.
    • Strong management and leadership skills
    • Working knowledge of OTC and ISO requirements.
    • Good verbal and written communication skills demonstrated by ability to generate technical reports.
    • Working knowledge of Quality tools (i.e., Quality Planning, Quality Costs and Assessment, Basic Statistics, Metrology and Calibration, Inspection and Testing, SPC, Sampling Principles and AQL).
    • Working knowledge of Problem Solving Tools (i.e., Process Mapping, Risk Analysis, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
    • Computer Skills and Information Technology (i.e., Microsoft Word, Excel, PowerPoint, Access, and Visio or equivalent, statistical software, Database Management).

    EXPERIENCE REQUIRED:

    • 3-5 years supervisory experience in laboratory, quality engineering or in manufacturing.
    • Minimum of 5 years’ experience in manufacturing under FDA 21 CFR 210 – 211 or ISO.

    SKILLS/ABILITIES:

    • Strong Leadership skills.
    • Strong communication and presentation skills.
    • Strong computer and information technology skills.
    • Good verbal and written communication skills demonstrated by the ability to generate reports.


    EDUCATION/CERTIFICATION:
    • Bachelor’s degree in Engineering, Science or Mathematics, or equivalent experience.


    REQUIRED KNOWLEDGE:
    • Strong analytical skills and ability to systematically approach problems and develop solutions.
    • Strong management and leadership skills
    • Working knowledge of OTC and ISO requirements.
    • Good verbal and written communication skills demonstrated by ability to generate technical reports.
    • Working knowledge of Quality tools (i.e., Quality Planning, Quality Costs and Assessment, Basic Statistics, Metrology and Calibration, Inspection and Testing, SPC, Sampling Principles and AQL).
    • Working knowledge of Problem Solving Tools (i.e., Process Mapping, Risk Analysis, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
    • Computer Skills and Information Technology (i.e., Microsoft Word, Excel, PowerPoint, Access, and Visio or equivalent, statistical software, Database Management).


    EXPERIENCE REQUIRED:
    • 3-5 years supervisory experience in laboratory, quality engineering or in manufacturing.
    • Minimum of 5 years’ experience in manufacturing under FDA 21 CFR 210 – 211 or ISO.


    SKILLS/ABILITIES:
    • Strong Leadership skills.
    • Strong communication and presentation skills.
    • Strong computer and information technology skills.
    • Good verbal and written communication skills demonstrated by the ability to generate reports.