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Quality Assurance Specialist, Sr.

MOUNTAIN, LTD. Summit Full-Time
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Title: Quality Assurance Specialist, Sr.
Location: Summit, NJ

Schedule: 8am to 5pm Mon – Fri.

Type: Temporary

Start date: ASAP

Responsibilities:

  • Conducts QA review and approve all manufacturing/processing batch records and quality test records.
  • Ensures completeness and accuracy of all files received into Quality Assurance, according to SOP and to meet state and federal regulatory requirements.
  • Ensures readiness of records for regulatory inspection.
  • Completes and provides data for Continuous Quality Improvement for all batch and quality test records per SOP.
  • Revises existing standard operating procedures as needed for annual review and process changes.
  • Reviews proposed changes to existing Standard Operating Procedures as needed
  • Assists in the review and release of raw materials for use in the manufacturing/laboratory area
  • Coordinates back room activities for Regulatory Inspections.
  • Reviews, compiles and organizes data for trending.
  • Provides assistance to other QA staff members as needed.
  • Performs other QA duties as assigned.

Requirements:

  • Bachelor's degree in a Life Science and/or equivalent work experience.
  • Basic understanding of medical terminology and/or cell therapies.
  • Detail oriented with high degree of focus.
  • Able to interpret and follow set policies and procedures.
  • Able to perform with minimal supervision and contribute in a team environment.
  • Able to communicate results and issues effectively, both written and orally.
  • Knowledgeable in Microsoft Office, with an emphasis in MS Word and Excel.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services.  For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

 

Skills required

Sample Procedure
Quality Assurance
Performance Testing
Perform Inspection
Total Quality Management
Provide Technical Guidance
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Job ID: BHJOB18630_142340

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WWW.MOUNTAINLTD.COM 

Engineering Services //

Since 1979, MOUNTAIN, LTD. has successfully created and supported turnkey engineering solutions for traditional and wireless telecom providers across the United States. We are a national leader in the industry, providing high-quality engineering, on-time service delivery, and skilled personnel paired with innovative technology and creative solutions. Specialties include OSP/ISP engineering, design, permitting, right-of-way and CAD for traditional and wireless telecommunications companies.

Program & Project Management //
Our expansive program and project management teams support traditional and wireless engineering work including resource & asset management, milestone tracking, real-time reporting, and turnkey delivery. We perform analysis of trends and risks to offer mitigation plans to implement innovative solutions.

Workforce Solutions //
Our experience extends beyond engineering projects. We can supplement your team with a variety of resources including administrative, professional, customer service, and IT personnel across diverse industries for any length of engagement. Our internal recruiting, on-boarding and bill/pay teams enable seamless management of our employees.

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