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QA Quality Analyst

4 months ago

Allentown, United States Advantage Technical Full time

Advantage Technical is seeking a QA Quality Analyst for our client in Allentown, PA.

Job Function - General:

  • Review and analyze documentation, procedures, and systems related to data integrity to identify potential gaps or deficiencies.
  • Prepare data Integrity gap assessment checklist as per protocol for evaluating data integrity practices across different departments and processes within the organization.
  • Conduct assessments of data Integrity practices to ensure compliance with regulatory requirements, including FDA data integrity guidelines, 21 CFR Part 11, and other relevant standards.
  • Collaborate with cross-functional teams including SMEs, Quality Assurance, IT, and Regulatory Affairs, to initiate data integrity assessment phase and communicate identified issues and implement corrective actions.
  • Monitor, track, and communicate progress of data integrity assessment, effectiveness of corrective actions and continuous improvement efforts as per assignment.
  • Stay updated on changes to regulatory requirements and industry best practices related to data integrity and incorporate them into assessment processes and procedures.
  • Prepare and present reports on assessment findings, recommendations, and compliance status to management as needed.
  • The function listed is not exhaustive and shall also include any responsibilities as assigned by the reporting Manager

  • Qualifications:
  • Bachelor's degree in a relevant scientific discipline, such as Pharmacy, Chemistry, Biology, or Information Technology.
  • Minimum of 2 years of experience in a pharmaceutical or biotechnology industry setting, with a focus on data integrity, quality assurance, or regulatory affairs.
  • In-depth knowledge of data integrity regulations and guidelines, including FDA data integrity guidance, EU GMP Annex 11, and PIC/S guidance.
  • Strong understanding of electronic document management systems, and laboratory systems and Manufacturing systems.
  • Excellent analytical skills and attention to detail, with the ability to identify and resolve complex data integrity issues. Proficient in utilizing Microsoft Office, Microsoft Project, and SharePoint.
  • Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams and communicate technical information to non-technical stakeholders.
  • Experience conducting assessments, audits, or inspections related to data integrity and quality management systems

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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 us. 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.