Senior Associate, Quality Assurance

Job Locations US-IN-Charlestown
ID
2021-2723
# of Openings
1
Category
Other

Overview

Maintains quality standards by performing routine incoming, in process and finished product inspections; approving incoming materials, in-process, and finished products; recording quality results. Enforces compliance with Knipper Quality Policy, SOP’s, cGMP, Operations Work Order Instructions, and all safety measures. Reviewing assembly, fulfillment, and receiving activities for conformance to company SOPs and current Good Manufacturing Practices and serves as the QA Subject Matter Expert.

Responsibilities

  • Provide guidance and direction for activities of QA Associates in coordination with Operations; motivate, develop, and provide additional training as necessary and in cooperation with QA Management.
  • Responsible for review and approval of inspection documentation; reporting inspection results including temptales as required; escalation of nonconformances as appropriate.
  • Act as backup to the QA Documentation Specialist for client requested inventory status changes and related memos at incoming inspection, and oversight of product destruction process through final disposition. 
  • Develop and maintain close working relationships with departmental managers to ensure adherence to internal policies and procedures and ensuring internal and external client expectation are being met.
  • Ability to recognize opportunities for improvement and develop possible solutions within QA department and communicate them to QA Management.   Perform other assignments as required by QA Management.
  • Performs incoming material and product inspections (including returned product as necessary) in accordance with documented procedures and sampling plans.
  • Performs line clearance activities in accordance with documented procedures, including assuring that appropriate materials/products are present for a job, paperwork is reviewed and understood, line set-up complies with cGMP and company SOPs; performs first piece inspection for conformance to written specifications (Operations Work Instruction) and sample; documents the results of line clearance inspections performed.
  • Performs random and scheduled inspections of print, assembly and kitting activities in accordance with documented procedures; documents the results of such line inspections when performed.
  • Documents all inspection results by completing reports and logs; verifying same is completed by assembly personnel as required; escalates nonconformance found during incoming inspections accordingly.
  • Maintains safe and healthy work environment by following standards and procedures.
  • Updates job knowledge by participating in educational opportunities; routinely reading standard operation procedures (SOPs), Department Work Instructions (WIs) and Operations Work Instructions.
  • Accomplishes Knipper quality mission by adhering to all quality standards.
  • Reports all concerns and questions to management.
  • Review reconciliation of product and/or components in assembly and fulfillment
  • Reviews and maintains all quality assurance inspection documentation and inspection logs.
  • Reviews and maintains all quality system paperwork involved with incoming inspection, line inspections, return inspections, assembly / production, and distribution activities in conformance with good documentation practices are readily retrievable.
  • May escort vendors for pest control, scale calibration and environmental monitoring.
  • Scope of responsibilities include: RECEIVING; PRODUCTION/ASSEMBLY; MATERIAL AND PRODUCT DESTRUCTION AND RECYCLING; DEA; PRINT. This job function has no supervisory responsibilities.

The above duties are meant to be representative of the position and not all-inclusive.

Qualifications

EDUCATION/TRAINING:  

  • High School Education or GED.
  • Experience in a regulated industry; two to three years’ experience in a Quality-related function and/or department.

KNOWLEDGE, SKILLS & ABILITIES:

  • 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 lift 30lbs
  • Ability to bend, reach and pull as necessary to meet daily demands of the job
  • Ability to sit or stand for long periods of time if necessary.
  • Willingness to engage in difficult conversations to seek a positive resolution
  • Ability to effectively communicate both orally and written with others.
  • Ability to be flexible to demands of the position.
  • Must be able to communicate in English; Spanish speaking is a plus.
  • Ability to interpret ANSI sampling standards
  • Working knowledge of current Good Manufacturing Practices and Good Documentation Practices.
  • Ability to use Microsoft Excel and Word at the following levels:
  • Word – Basic Level: This level of skills is sufficient to perform daily word processing tasks, such as, producing routine letters, memorandums, and informal reports. A person with this level of skills is able to use basic formatting, editing, printing functions, and understands the document page setup.
  • Excel – Intermediate Level: This level of skills is required to work with multiple worksheets, filter data, use integrate functions, and manipulate databases. With this level of skills, a person understands the concepts of databases and is able to work with charts and to use the list management capabilities of Excel.
  • Proficient in use of computers and ability to learn internal software programs; TimeTrak, SCALE, and ProMail.

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