Quality Assurance Analyst

2 weeks ago


Summit, New Jersey, United States Sunrise System Inc Full time

Job Title: Quality Assurance Analyst
Company: Sunrise System Inc
Location: Summit, NJ
Duration: 12 Months contract on W2

POSITION SUMMARY:

The Quality Assurance Analyst is integral to upholding the cGMP quality standards for Vector External Manufacturing. Key responsibilities encompass the examination of cGMP Controlled Documents, including SOPs, specifications, and completed batch records, while overseeing the implementation of necessary modifications to align with cGMP and internal benchmarks. This role is pivotal in facilitating the release of vector timelines post-manufacture and supports all activities related to routine clinical and commercial product releases, emphasizing a Quality perspective within a regulated cGMP setting.

CORE RESPONSIBILITIES:

The primary objective of the QA Analyst is to assist in routine clinical and commercial production, ensuring unwavering compliance with regulatory and industry standards. The QA department relies on this role to foster a Quality-focused culture by guaranteeing that documentation is thorough, precise, and that batch records are processed in accordance with approved and effective standard operating procedures and specifications.

QUALIFICATIONS:

Education: A Bachelor's degree in a relevant scientific or engineering field is preferred, with a minimum of an Associate's degree.

Experience:

  • 3-5 years of pertinent cGMP experience, particularly in FDA/EMA regulations within biopharmaceuticals or cell therapy manufacturing.
  • Practical experience in batch record review and product disposition is advantageous.
  • Proficient in computer applications such as Word and Excel, along with other electronic manufacturing systems.
  • A detail-oriented team player with strong planning, organizational, time management, and execution capabilities.
  • Demonstrated experience collaborating within teams to achieve collective results.
  • Ability to exercise sound judgment and critically assess information to determine appropriate actions.
  • Capacity to thrive in a fast-paced team environment.
  • Excellent written and verbal communication skills.
  • Licenses/Certifications: Not applicable.


WORKING CONDITIONS:
  • The employee frequently engages in standing, walking, sitting, bending, stretching, and utilizing hands and fingers for various tasks, as well as effectively communicating with colleagues in the workplace.


This job description is designed to outline the general nature and level of work performed by the individual in this role. The primary duties and responsibilities are intended to highlight essential functions of the position.
This description does not imply that the aforementioned duties are the only responsibilities assigned to this role. Additional duties considered incidental or secondary to the primary purpose of this position may be required as directed by management.



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