Quality Assurance Specialist

SGS Consulting; Durham (NC); On-site; USD 58,000 - 72,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

SGS Consulting seeks a Quality Assurance Associate II for a 6-month contract position at their RTP facility in Durham, NC. The role focuses on supporting large-scale manufacturing with a primary emphasis on the review and approval of critical documentation to ensure compliance with cGMP regulations. Ideal candidates will have relevant experience in biomanufacturing and a strong understanding of quality assurance processes.

Qualifications

• 1+ years of experience in biomanufacturing or quality assurance.
• Strong ethic and commitment to cGMP standards.
• Experience with batch related documentation.

Responsibilities

• Review and approve batch documentation related to quality assurance.
• Support compliance with regulatory standards and safety protocols.
• Assist with GMP training and quality management systems.

Skills

cGMP knowledge

Quality Assurance

Documentation Review

Education

Bachelor's Degree in a relevant field

Job description

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This range is provided by SGS Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$28.00/hr - $31.00/hr

Direct message the job poster from SGS Consulting

Recruiting Team Lead || US Staffing || Pharmaceutical, Clinical & Healthcare Industry ||

Description:

Manager’s note:

• This is a supportive QA role focused on Review and approval of Solution lot records, reports, logbooks, and release of autoclaved equipment. The contractor will be supporting Large Scale Manufacturing.
• Please ensure candidates have a strong ethic and knowledge of cGMP in a Biomanufacturing field. 1+ years' experience would be amazing.

RTP Onsite

Duration: 6 Months

The Quality Assurance Associate II (Contractor) is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Client Research Triangle Park (RTP) facility. Activities include but are not limited to a review of GMP raw data for compliance. The QA Associate II will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures and adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers.

Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) to support product disposition.

• Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.

• Supports resolution of both technical and compliance issues/gaps of mild to moderate complexity.

• Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by client.

• Complete and maintain related GMP training.

• Additional job duties that may be assigned from time to time.

• 0-2 years directly related to position responsibilities or biologic experience preferred.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Production, Manufacturing, and Science

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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