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QA Specialist

2 months ago

Rockford, United States TekWissen LLC Full time
Job DescriptionJob DescriptionOverview TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: QA Specialist Location: Rockford, IL, 61101 Duration: 12 Months Job Type: Contract Work Type: Onsite Shift : Monday to Friday 1st Shift Job Description:Position Summary:
  • Provide Quality Assurance Support to the Rockford site.
  • Provide product and quality system information to internal and external customers.
  • Review new paperwork and proposed changes for appropriateness and determine potential effects on product quality.
  • Help strengthen our quality system and make improvements where needed. Help educate and promote adherence to Quality Assurance policies and requirements. Work with Quality Control in the review and development of specifications, test methods and protocols.
Key Responsibilities:
  • Provide Quality Assurance Support to the Rockford site
  • Complete Customer surveys and specification verifications
  • Review and approve engineering change notices and deviations for appropriateness and to determine potential effect on product quality
  • Assist with the maintenance of ISO registration and the internal audit program
  • Investigate quality problems
  • Perform and coordinate review of raw materials to determine continued suitability at retest/review dates
  • Assists with creation/modification of Certificates of Analysis templates
  • Assist Customer Service, Technical Support, Regulatory Affairs, and Analytical Services in addressing customer inquiries and concerns
  • Process product integrity customer complaints
  • Perform training on Quality procedures
  • Gather and maintain Country of Origin and animal origin information
  • Review and update standard operating procedures
  • Perform inspection of incoming products as needed
  • Collect and analyze quality data
  • Participate, as needed, on new product teams
  • Perform all job duties in a safe manner and obeys all safety policies and procedures
  • Perform all job duties consistent with the Code of Ethics and the 4-I values
  • Perform all job duties within ISO standards, regulatory or statutory requirements
  • Perform other duties and cross training as assigned
Minimum Requirements/Qualifications:
  • Bachelor's degree required in a client discipline
  • 1+ years related experience in a manufacturing or quality environment
  • Strong written and oral communication skills
  • Must be able to communicate effectively with multiple levels of staff throughout the organization
  • Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
  • Detail-oriented and accurate while maintaining a vision of the result
  • Employee must be self-motivated with the ability to work as a team player and/or independentl
  • Knowledge of ISO and cGMP requirements preferred
  • Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
  • Bachelor's degree in science required. Looking for QA experience (RCCM, Complaint handling, CAPA), not QC (lab work).
TekWissen Group is an equal opportunity employer supporting workforce diversity.