Analytical Data Auditor (11339896)

St. Petersburg, FL

Posted: 10/30/2020 Industry: Quality Assurance Documentation Job Number: JN -102020-12149

Job Description

Analytical Data 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: Analytical Data Auditor
  • Location: St. Petersburg, FL
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am 5:00 pm
  • Salary: Up to $33 hour paid weekly with benefits options
  • Employment Type: Contract 6 months with possible extension or conversion

Job Scope: The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, and in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of products and materials. The department provides analytical services to manufacturing, process development, validation, and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also supports CMC development activities in support of client regulatory filings. Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg s Quality departmental policies.

Basic Function: Independently review and audit analytical data including notebooks, chromatographic data, validation protocols and reports and other analytical data protocols and reports. Document and communicate results both to the analysts whose work is under review and to laboratory management when required. Maintain proper records in accordance with all SOP's and policies
  • Perform audits of analytical data to include but not limited to laboratory notebooks, chromatographic raw data, analysis reports, and other analytical data as required, against test methods, specifications, and other reference documents.
  • Initiate/facilitate/review documented deviations/process discrepancy reports/investigations of any reported or observed nonconformance found relative to data quality.
  • Approve analytical documents as the reviewer against applicable specifications/procedures
  • Perform data certification in the electronic LIMS system if applicable.
  • Actively participate in corrective actions and continuous improvements.
  • Assist in complying with any other company and /or departmental objectives as directed by AR&D management.
  • Deliver on commitments to meet customer expectations.

Skills Needed:
  • MS in scientific field with 3 plus years, or BS in scientific filed with 5years or AS in scientific filed with 10 years in the analytical lab.
  • Analytical laboratory / Pharmaceutical and or GMP experience preferred
  • Experience with data auditing in a GMP/pharmaceutical enviornemt.
  • Prior quality assurance experience with CMC review is preferred.
  • Working knowledge of cGMPs regulations.
  • Certified Quality Auditor is a plus
  • Proficient in Microsoft Office. Good word processing skills.
  • Ability to work effectively under pressure to meet deadlines.
  • Vision requirements include reading of English documents and distinguish color.
  • Must possess good interpersonal skills.
  • Ability to effectively communicate with co-workers.
  • Good organizational skills required.
  • Excellent oral and written communication skills
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