Quality Assurance (QA) Specialist


North Chicago, Illinois

12 days ago

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Job Description

Job Title: Quality Assurance (QA) Specialist
Location: 100% Remote
Duration: 12 Months
Job Responsibilities:
  • Independently resolves routine issues. Handles complex problems by proposing potential management solutions.
  • Contributes to departmental policy.
  • Review, develop, and monitor global pharmacovigilance compliance metrics.
  • Leads the preparation and conduct of PV relevant, internal, and external global audit and inspection process, responses, and develops associated improvement plans (e.g., EMA, MHRA, FDA; response to warning letters or USFDA 483s)
  • Review and triage of reports of non-conformances and potential non-conformances using professional judgment and expertise
  • Review and approve exception reports, planned deviations, and CAPA tasks in line with internal and regulatory requirements.
  • Review, evaluate, and propose necessary regulatory guidance changes (e.g., ICH).
  • Evaluates and develops appropriate work tools and methodologies to enable staff to improve performance and productivity continually
  •  Actively identify, propose, and implement improvements while fully engaging in new initiatives to continually support the advancement of the Audit/Inspection process, PV investigation/CAPA process, and Planned Deviation process.

  •  Bachelor’s degree with related health science background or quality background;
  • Minimum 4 years clinical experience or 3 years related pharma experience.
  • Must have solid technical and English writing skills to support root cause analysis and CAPA process.
  • Must have background supporting Audits, Inspections, and Deviation.

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.