at Spectraforce Technologies Inc. in WaukeganNorth Chicago, Illinois, United States
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.
Qualifications:
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.
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 nahr@spectraforce.com if you require reasonable accommodation.
