Overview
QA Associate III/Sr. QA Associate I Jobs in Wilmington, OH at Alkermes, Inc.
Quality Compliance, Audit and Risk Operations GVP/GXP- Pharma (Hybrid- Lawrenceville, NJ)
We are looking for a Quality Compliance, Audit and Risk Operations GVP/GXP- Pharma (Hybrid- Lawrenceville, NJ) for a global pharmaceutical company. This role supports the Market Research (MR) Compliance and Operations Team under direction and guidance from the MR Compliance Lead. The coordinator works cross-functionally, supporting Analytics activities related to Market Research and GVP Activities to ensure that internal audit responses, the third-party risk process, and reporting are performed accurately and with sufficient detail.
This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role in Lawrenceville, NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities:
Develop an understanding of the regulations, methodology and processes that drive Market Research to ensure client’s compliance with program requirements
Prepare and support audit activities for MR Pharmacovigilance Vendor and Affiliate audits and Inspections. Activities include working closely with PV Audit teams and vendor partners to ensure timely closure of Audit activities and continuous monitoring of trends.
Manage internal vendor onboarding, including Third Party Risk Management (TPRM) process and system, which includes engaging vendor agencies, responding to requests and remediation of identified issues, and escalating issues to the Compliance Lead
Own document tracking and data governance for requests and maintain schedule of deadlines
Provide reporting and analytical support to ensure compliance with government program regulations
Partner with internal stakeholders in order to provide status updates and manage expectations
Implement continuous improvement procedures to maintain operational effectiveness; making recommendations to strengthen and streamline the process and controls in place
Requirements:
4+ years of experience in an audit or compliance support role
Intermediate knowledge of MS Excel, specifically formulas, pivot tables and charts
Experience with pharmaceutical industry preferred
Strong background in Quality Management Systems, Compliance or Quality Assurance preferred
BA/BS in relevant field of study or equivalent required
Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Quality Compliance, Audit and Risk Operations GVP/GXP- Pharma (Hybrid- Lawrenceville, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $48/hr – $53.57/hr.
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Title: QA Associate III/Sr. QA Associate I
Company: Alkermes, Inc.
Location: Wilmington, OH
