Quality Assurance Specialist at Pinnacle Staffing Group Phoenix
Tempe, AZ 85282, USA -
Full Time


Start Date

Immediate

Expiry Date

30 Nov, 25

Salary

90000.0

Posted On

31 Aug, 25

Experience

3 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Microsoft Office, Ppk, Analytical Skills, Gr&R, Control Charts, Outlook, Six Sigma, Cp, Time Management, Communication Skills, Multitasking, Excel, Powerpoint, Iso, Lean Manufacturing

Industry

Pharmaceuticals

Description

The Quality Assurance Specialist is responsible for ensuring products are built in accordance with quality plans to achieve overall customer satisfaction. This role protects the customer from internal quality issues and proactively identifies and implements processes to address quality risks. The Quality Assurance Specialist responds to internal and external inquiries and ensures all issues are tracked, addressed, and resolved appropriately.

Responsibilities:

  • Implement plans and solutions to proactively address quality risks related to products and processes
  • Develop and maintain Quality Management System (QMS) procedures to meet customer and regulatory standards
  • Build effective working relationships across internal teams, customers, and vendors to address and resolve quality concerns
  • Manage and sustain CAR/PAR processes, ensuring timely and effective corrective action
  • Perform root cause analysis and ensure corrective actions are implemented for non-conformances, incoming inspection failures, and customer complaints
  • Plan and conduct in-process inspections to ensure compliance with QMS procedures
  • Track, analyze, and report quality trends (e.g., NCRs, CAR/PARs, FPY, PPM) to support continuous improvement
  • Develop criteria for incoming inspections, including sampling procedures, measurements, documentation, and training
  • Coordinate Material Review Board (MRB) meetings for disposition of non-conforming materials
  • Support process improvement initiatives to enhance production accuracy and repeatability
  • Participate in Engineering Change Management by evaluating change plans and risk assessments
  • Conduct internal and external QMS audits
  • Maintain and oversee document control systems
  • Develop and deliver training to improve QA/QC knowledge and understanding of quality standards
  • Perform internal audits and maintain an audit schedule aligned with ISO 9001:2015 standards
  • Participate in safety programs and adhere to company health and safety policies
  • Perform other duties as assigned

Qualifications:

  • Diploma or degree in a related discipline
  • Minimum 3 years of relevant quality assurance experience
  • Strong troubleshooting and analytical skills
  • Ability to learn new processes quickly and apply problem-solving techniques
  • Familiarity with ISO 9001, Six Sigma, Lean Manufacturing, DFM, FMEA, APQP, GR&R
  • Strong understanding of manufacturing statistics (Cp, Cpk, Pp, Ppk, control charts, DOE)
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Excellent verbal and written communication skills
  • Highly organized with strong time management and multitasking abilities
  • Able to work independently and collaboratively in a fast-paced environment

Required Training (or willingness to complete):

  • Controlled Goods Policy & Application

How To Apply:

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Responsibilities
  • Implement plans and solutions to proactively address quality risks related to products and processes
  • Develop and maintain Quality Management System (QMS) procedures to meet customer and regulatory standards
  • Build effective working relationships across internal teams, customers, and vendors to address and resolve quality concerns
  • Manage and sustain CAR/PAR processes, ensuring timely and effective corrective action
  • Perform root cause analysis and ensure corrective actions are implemented for non-conformances, incoming inspection failures, and customer complaints
  • Plan and conduct in-process inspections to ensure compliance with QMS procedures
  • Track, analyze, and report quality trends (e.g., NCRs, CAR/PARs, FPY, PPM) to support continuous improvement
  • Develop criteria for incoming inspections, including sampling procedures, measurements, documentation, and training
  • Coordinate Material Review Board (MRB) meetings for disposition of non-conforming materials
  • Support process improvement initiatives to enhance production accuracy and repeatability
  • Participate in Engineering Change Management by evaluating change plans and risk assessments
  • Conduct internal and external QMS audits
  • Maintain and oversee document control systems
  • Develop and deliver training to improve QA/QC knowledge and understanding of quality standards
  • Perform internal audits and maintain an audit schedule aligned with ISO 9001:2015 standards
  • Participate in safety programs and adhere to company health and safety policies
  • Perform other duties as assigne
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