SR Analytical Quality Auditor

Morrisville, NC

Posted: 03/30/2022 Industry: Lab Technician/Assistant Job Number: JN -032022-14415 Division: Life Sciences

Job Description

SR Analytical Quality Auditor

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

  • Title: Senior Analytical Quality Auditor
  • Location: Morrisville, NC.
  • Industry: Pharmaceutical
  • Hours: Shift M-F 8am 5:30pm
  • Salary: $45hr (Paid Weekly - Benefits Available)
  • Employment Type: 3 Month - Contract to Hire

Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Summary:
The Sr. Auditor is a resource and go to person for other individuals within the department and is able to perform routine to complex auditing of pharmaceutical projects across functional areas using established procedures. This position can work independently with minimal to no supervision and is able to work with progressively more involvement in recommendations for the improvement of the department and systems. He/she can make judgments on observations with limited to no supervisory
review. This position requires a good degree of initiative to resolve problems. He/she discusses and research actions to be taken before finalizing a resolution. Comply with divisional and site Environmental Health and Safety requirements.

Knowledge, Skills and Abilities:

  • 6-8 years of quality assurance for a GMP testing lab (QC or biologics)
  • The employee must have a good understanding of chemistry/lab practices and be able to
    function independently with supervision
  • Good communication with multiple individuals and departments and organizational skills are
  • Requires knowledge of cGMP, GLP, ICH, and USP regulations or guidelines
  • Requires contact with multiple departments and on occasion with customers
  • May require formal presentation to individuals or groups
  • Usually supplies and seeks information where exceptional tact and courtesy is needed
  • Considerable knowledge of one or more major scientific technique to establish compliance
  • Direct interaction with onsite customer visits and telephone/email requests
Education and Experience:
  • Bachelor s degree in chemistry or closely related physical science from a four-year
    college/university or equivalent education and job experience
Specific Duties, Activities and Responsibilities:
  • Audit a variety of methodologies as applied to various stages of pharmaceutical development.
  • Verify accurate transcription of raw data into reports.
  • Audit above testing for compliance to all applicable SOPs and regulatory requirements.
  • Discuss issues with lab staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits.
  • Archive study phase documentation in a timely manner.
  • Identify potential compliance issues and takes corrective measures to prevent them, participating on assigned teams as required.
  • All other duties as assigned.

Must be on site


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