Senior Analyst, PQA
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
The Senior Analyst Post-Market Surveillance is part of AbbVies Medical Device Center within the Shared Services function (MDCSS). This positions primary focus is on Post-Market Risk and reports to the Manager Post-Market Device Quality (or equivalent).
The role performs a variety of tasks related to maintenance and post-market evaluation of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820 MDR 2017/745 EN ISO 13485). Primary responsibility is Post-Market Reporting (e.g. PMCF PMSR PSUR etc.) however the role may also entail analyzing complaints analyzing post-market signals collecting data and evaluating other measures of product performance (e.g. CAPA/NCR).
The Senior Analyst Post-Market Surveillance serves as a cross-functional team advocate tasked with
assuring stakeholder concerns are addressed during planning and/or execution of assigned activities.
- Assess trends escalated by Signal Detection as assigned
- Conduct investigations for CAPAs NCRs Observations etc.
- Coordinate and schedule post-market reporting activities (e.g. CERs PMCFP/PMCFR PMSP/PMSR/PSURs etc.)
- Author or update Post-Market Reporting documents (e.g. PMCFP/PMCFR PMSP/PMSR/PSURs PRER etc.)
- Work with internal business partners to ensure timely collection and assessment of relevant data (e.g. complaint trends literature reviews medical assessments) to drive evidence-based conclusions regarding product performance and safety
- Escalate discrepancies and confirmed or potential Quality issues to management
- Develop Quality Plans and manage projects as assigned
- Support interactions with regulatory authorities (e.g. Notified Body audits)
- Write and revise process-related procedures forms and other documents as needed
Qualifications :
- Bachelors degree preferably in Engineering or Science
- Six years of experience within the Pharmaceutical operations preferably Biologic manufacturing process
- Knowledge of GMP regulations and standards affecting pharmaceutical products
- Comprehensive knowledge and application of business and quality concepts
- Strong analytical skills and attention to detail
- Change plan Exception Reports SAP and LRMS experience is highly preferred
- Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
- Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Preferred Qualifications
- Experience with ComplianceWire Global TrackWise and/or OneVault
- Experience working with EU MDR 2017/745 21 CFR 820
- Working knowledge of current MDCG relevant to Post-Market Reporting
- Experience with post-market reporting and/or data analysis
- Scientific/Medical background
- ASQ Certification (e.g. CQA CQE) or equivalent
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Splunk
- IDS
- Microsoft Access
- SQL
- Cybersecurity
- Intelligence Experience
- Malware Analysis
- Tableau
- Analysis Skills
- SAS
- Data Analysis Skills
- Analytics
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
