Quality Technician II in Big Flats, New York at AccruePartners

Date Posted: 7/14/2020

Job Snapshot

Job Description

AccruePartners values our contract and consulting employees. We offer a competitive benefits package to meet the diverse needs of all of our contractor and consulting employees and their family members. Here is a listing of what our company offers: 401(k) Medical, Dental, Vision, Life Insurance, Employee Assistance Program, Medical and Prescription Drug, Short and Long-Term Disability Insurance.

WHO OUR CLIENT IS:

  • Fortune 500 manufacturing and technology organization with significant investment in R&D and Innovation.
  • Rich history with over 150 years of significant growth and innovation
  • Expanding global footprint in North America, South America, Europe and Asia
  • Industry leader within all 8 divisions and leader in each
  • Known for growing talent internally and promoting internally

WHY YOU SHOULD CONSIDER THIS OPPORTUNITY:

  • Culture: Highly collaborative, teamwork-oriented environment
  • Growth: Make an immediate impact in this high visibility role
  • Opportunity: Ability to drive change within organization with a focus on process improvement
  • Stability: Strong executive leadership team investing in its talent and elevating the global footprint

WHERE THIS POSITION IS LOCATED:

  • Big Flats, NY

WHAT YOU WILL DO:

  • Overall Quality Assurance responsibility for final batch release including ware evaluation and disposition and ensuring QA/QC closure of deviations and non-conforming (NC) ware
  • Responsible for day-to-day activities related to documentation and quality support of multiple manufacturing lines
  • Proactively address customer quality needs by implementing methods and procedures to ensure that products meet/exceed customer requirements.
  • Supports job changes and validation activities across multiple production lines

Day-to-Day Responsibilities

  • Collect daily paperwork from manufacturing floor, review for accuracy and good documenation practices (GDP); communicate with Operations to ensure all paperwork is complete
  • Track and Compile Batch History Records for every manufacturing batch
  • Track and process NCs and deviations Assign document numbers
  • Ensure documentation is filed and secured
  • Participate in line clearance and batch start-up activities to assure cGMP compliance
  • Execute the Incoming Quality Assurance (IQA) procedures- check the incoming raw materials and packaging materials, complete all Quality Assurance responsibilities
  • Track and sign off on Metrology forms related to process monitoring and batch release
  • Attend Material Review Board meeting and document ware disposition (Accept, Reject, Released to Pallet); manage material disposition and batch release testing in MES database
  • Ensure ware disposition to pallet: verify Accepted ware on pallets and pallet is built to customer requirements per Item Specification
  • Execute job change verifications with Operations/Engineering; manage associated documentation
  • Support validation activities as needed
  • Participate in audits (internal and external) and support follow-up activities
  • Train and supervise contract employees as needed
  • Perform additional duties as assigned by supervisor


HOW YOU ARE QUALIFIED:

  • Able to handle complex tasks, work independently with strong time management and prioritization skills to handle multiple assignments and interact with cross-functional project teams.
  • Understanding of quality principles, practices and procedures to meet cGMP compliance
  • Experience using Microsoft Office (Word, Excel, Outlook) and software applications
  • Working knowledge of databases
  • Able to read, understand and adhere to documented procedures
  • Desired Experience /Qualifications /Skills
  • Experience with Camstar manufacturing execution system (MES)
  • Experience working in an ISO and/or regulated industry environment
  • Experience working in pharmaceutical, medical device or automotive industries.

Soft Skills:

  • Strong written and verbal communication skills
  • Attention to detail
  • Organized with good planning and time management skills
  • Ability to build relationships within cross functional groups; team building skills
  • Positive attitude, flexible and good work ethic
  • Results oriented and high commitment
  • Able to react to change and perform other duties as assigned