Quality Documentation Clerk - 2nd Shift

TekniPlexClayton, NC
Onsite

About The Position

TekniPlex is a global team of problem-solvers whose innovations in materials science aim to make life better. The company helps turn ideas into impact using science, technology, and creativity to tackle real-world challenges, improving patient outcomes in healthcare and protecting essential consumer goods. TekniPlex has over 8,000 colleagues across 12 countries, united by the purpose of creating safer, smarter solutions that touch daily life. Through its two divisions, TekniPlex Healthcare and TekniPlex Consumer Products, the company shapes industries such as healthcare, pharmaceutical, food & beverage, beauty, and personal care. Employees are encouraged to think boldly, collaborate across cultures, and grow professionally, contributing to protecting product integrity, supporting patient safety, and innovating for everyday life. TekniPlex is hiring a Quality Documentation Clerk for its Clayton, NC facility. As part of the Quality Team, the QA Documentation Clerk is responsible for document control and related activities, including preparing packages for product shipments.

Requirements

  • High school diploma or equivalent and 2 year’s previous quality assurance experience or a combination of education and experience.
  • Ability to input and retrieve information from computer software.
  • Basic understanding of blue print reading, process equipment and inspection instruments.
  • Strong attention to details.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
  • Ability to write routine reports and legibly complete time cards and work orders.
  • Ability to read, analyze, and interpret technical procedures and read blueprints and technical drawings, such as machine, mechanical, pneumatic, hydraulic, and electrical.
  • Ability to effectively present information in one-on-one and small groups situations to other employees of the organization.
  • Ability to effective present information and respond to questions form groups of managers, clients, customers, and the general public.
  • Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to compute rate, ratio, and percent.
  • Ability to apply concepts of basic algebra, geometry, fractions, percentages, ratios, and proportions to practical situations.
  • Ability to solve practical problems and deal with a variety of variable in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

Responsibilities

  • Controls and maintains quality documents utilizing systematic record keeping methods:
  • Prepares document packages for product shipments.
  • Reviews entire batch record for accuracy and completeness of paperwork including labels and SPC charts. Works with operations personnel to correct any discrepancies.
  • Maintains batch record files in an organized manner.
  • Accurately enters production data in the creation of Certificate of Compliance, SPC charts, etc.
  • Input new key item numbers, changes and revisions from cost sheets, updating label data base and creating Statistical Control Charts.
  • Supports current item key data base as needed.
  • Interfaces with Customer Service for information related to item keys.
  • Reviews drawing for new item keys.
  • Review sales orders before released to production floor
  • Maintains work order books (medical extrusion and subassembly).
  • Maintain customer drawings/specifications.
  • Customer Kanban System.
  • Maintains inventory levels and manages work order packages and paperwork to enable accurate shipments.
  • Supports investigations of customer complaints, collecting data/reducing data, and establishing corrective action.
  • Support and maintain Quality Management Systems (Quality Manual, Procedure Manual, Work Instructions, and Forms).
  • Performs other duties as assigned.

Benefits

  • Medical Coverage
  • Prescription Drug Coverage
  • Telemedicine
  • Dental Coverage
  • Vision Coverage
  • Employee Assistance Program
  • Health Savings Account (HSA)
  • Flexible Spending Account (FSA)
  • Basic Term Life/AD&D Insurance
  • Voluntary Life/AD&D Insurance
  • Short Term Disability (STD)
  • Long Term Disability (LTD)
  • Voluntary Buy-Up LTD
  • Hospital Indemnity
  • Accident Insurance
  • Critical Illness
  • 401(k) Retirement Savings Plan
  • Daily Pay
  • Business Travel Insurance
  • Legal Plan
  • Identity Protection
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