QA Coordinator/Associate (this is NOT a remote role)
Location - Rahway, NJ
Do you want to be responsible for performing review, coding, and entry of audit report findings, assists with facilitation of Corrective and Preventative Actions (CAPAs), and participates in GCP related projects? Participates in facilitating or co-audits as experience increases and proficiency is demonstrated.
Who are we?
We Are PRA.
We are 18,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Who Are You?
You are an experience professional with a passion for clinical supplies. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
Still here? Good. Because if this is you, we’d really like to meet you.
What Will you Be Doing?
This individual will be expected to support the review and revision of Quality Agreements with our clinical contractors who perform a diverse set of services for Merck in laboratory, manufacturing, packaging and distribution spaces. This may also include supply relationships with commercial sites.
This requires an individual with strong communication skills, ability to understand complex supply chains and ability to quickly develop organizational awareness/savvy.
Additionally this individual will support as capacity permits: maintenance activities associated with our electronic supplier management systems. CAPA verification activities for commitments post audit Administrative functions associated with the audit request and schedule process.
Applies knowledge of ICH GCP to interpret audit findings and conduct peer reviews (as appropriate).
Generates initial response to general ICH GCP questions.
Facilitates tracking of escalated issues to resolution.
Communicates with multiple levels within the organization.
Supports implementation of revised processes and procedures.
What Do You Need to Have?
Education and Work Experience:
An undergraduate degree or its international equivalent from an accredited institution preferred.
Preferably in the health-sciences or computer sciences.
Knowledge, Skills, and Abilities:
Experience in clinical research organization is preferred.
Basic understanding of ICH GCP, FDA CFR, and EU directive.
Read, write and speak fluent English; fluent in host country language required.
Working knowledge of the Clinical Trial Supply process.
Working knowledge of project team structure and processes.
Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution.
Knowledge of project management and Clinical customer relationship building.
Knowledge of the ‘Customers’ team structures and processes.
Excellent verbal and written communication skills.
Ability to influence others.
Ability to multi-tasks.
Strong organizational skills.
Experience in conflict resolution and negotiation skills.
Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now our in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.