Senior Specialist, Quality Assurance, Clinical Quality

Merck•Rahway, NJ

4d•$106,200 - $167,200•Remote

About The Position

Our Research Laboratories Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research Laboratories QA Clinical Quality (CQ) provide independent assurance that our company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

Requirements

BS/BA degree or equivalent and/or 3-5 years experience in a relevant field, along with proficiency in the primary activities and essential skills required for this role.
Analytical Thinking
Audits Compliance
Clinical Research
Clinical Trials
Detail-Oriented
Ethical Compliance
GCP Auditing
Investigative Skills
Metrics Analysis
Multiple Therapeutic Areas
Process Improvements
Stakeholder Management
Taking Ownership
Technical Documentation Management
Time Management

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Valid Driving License: No
Hazardous Material(s): n/a

Responsibilities

Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work
Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills
Influences, partners and collaborates with other colleagues within and outside their team
Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based audits
Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities.
In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate.
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.
Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our company policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of Quality Assurance, regulations and auditing.
Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
Promotes standardization of auditing approach within QA.
Routinely suggests new audit techniques/aids in areas of technical expertise.
Ensures the work climate/culture within QA, exemplifies the company's Leadership behaviors