Regulatory Affairs Associate- Laboratory

3 days ago

Cambridge, United States Advantage Technical Full time

Laboratory Affairs Associate- QC LAB- FDA

Job Length-One year with possible extension

Remote with some onsite presence as needed

LOCATION: Cambridge MA

Hourly Rate: 53 an HOUR

B.S. in chemistry, biology, or biochemistry, or related scientific field; Pharmaceutical/Biotech industry experience with 5 years in a GMP Quality Control function or equivalent, relevant industry experience with demonstrated increase in responsibility Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach Demonstrated technical writing skills, with preference for technical writing of investigations Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making Solid problem-solving skills and experience in conducting investigations and implementing CAPA Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

Overview

The Analyst IV Dossier Data Integrity in Quality Control Operations - Contractor is an individual contributor responsible for ensuring the high standards of quality and compliance are met in support of commercialization of company programs.

The Analyst IV Dossier Data Integrity in Quality Control Operations - Contractor, is responsible to assure the completeness, consistency, and accuracy of regulatory filings, laboratory data and reports. This is accomplished by reviewing regulatory filings against source methods or reports as specified by Standard Operating Procedures.

This position is flexible for remote working with some on-site presence anticipated at Norton, MA and Cambridge, MA, as needed. Some travel to CMO/CTL sites may be necessary.

Key Responsibilities (including but not limited to):

Verify the integrity and traceability of regulatory dossier sections. Review regulatory dossier sections against associated reference methods and reports for accuracy in data reporting/transcription.

  • Review analytical data for accuracy in data reporting/transcription and for complete and correct entries of all associated references. Verify the integrity and traceability of all data generated and reported.
  • Review data documented by laboratory personnel within laboratory notebooks, worksheets, logbooks (e.g., instrument use and maintenance logbooks) along with respective electronic data.
  • Review complex notebooks involving analytical method validation, verification and transfer testing and ensure that the testing is conducted as per approved protocols and methods.
  • Review audit trail to ensure that the electronic data were generated according to applicable procedures.
  • Ensures that all the affiliated data including electronic data and respective notebooks/logbooks are complete and reviewed.
  • Discuss with client when necessary to resolve all required corrections to analytical data or reports.
  • Works in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  • Consult with management regarding priority of assignments. Provide communication to management of any deviations/discrepancies noted during the review process. Provide feedback and suggest ideas to improve the review process.
  • Perform any other duties as assigned by the management.

    Qualifications:



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About Advantage Technical

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

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