Compliance Specialist

Posted Yesterday
Be an Early Applicant
Southborough, MA, USA
In-Office
Senior level
Information Technology • Consulting
The Role
Support QA activities including reviewing quality-critical alarms and NRSRs, reviewing J&Cs, entering metrics into databases, initiating and investigating deviations, conducting deviation containment (including off-hour support), providing off-hour batch record issuance support, acting as backup to the QA Manager, and performing other assigned quality-related tasks.
Summary Generated by Built In
Company Description

We are next gen digital transformation, technology consulting, enterprise IT and product engineering services firm

Job Description

Review of Quality Critical Alarms and NRSR

Review J&Cs

Metric entry into database

Initiate and investigate deviations for non-conformance

Conduct deviation containment assessment (off-hour support)

Provide off-hour support for batch record issuance

Function as back-up for QA Manager

Other activities as assigned


QUALIFICATIONS:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards,

and to continually pursue excellence in the development and delivery of all of our products and services. This

includes:

Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our

own Company policies and procedures.

Being honest and treating people with respect and courtesy.

Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its

people and products.

Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and

exercising sound judgment in performing our jobs.


BASIC QUALIFICATIONS:

Bachelor’s Degree in a scientific field and 4-6 years experience in a Quality and /or other cGMP related field,

or Master’s Degree in a scientific field and 2 years’ experience in above.

2 years of experience in a Quality role.

Knowledge in external agency regulations (FDA, EMA, etc.)

Strong computer, verbal and written communication skills.

Experience in quality systems.

Experience in leading cross functional team.

Experience with Track wise or equivalent system.

Proficient in Microsoft Office.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Skills Required

  • Bachelor's degree in a scientific field and 4-6 years' experience in a Quality and/or other cGMP related field, or Master's degree in a scientific field and 2 years' experience
  • Minimum 2 years of experience in a Quality role
  • Knowledge of external agency regulations (FDA, EMA, etc.)
  • Experience with quality systems and leading cross-functional teams
  • Experience with TrackWise or equivalent quality management system
  • Proficiency in Microsoft Office
  • Strong computer, verbal and written communication skills
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: San Jose, CA
2,064 Employees
Year Founded: 1992

What We Do

ACL Digital is a design-led Digital Experience, Product Innovation, Solutions, and Consulting offerings leader. From strategy, to design, implementation, and management we help accelerate innovation and transform businesses. Keeping customer journeys and design at the core, it is committed to enable large Enterprises, SMBs and start-ups to transform. A pioneer in delivering Business Innovation, Integration and Transformation through disruptive technologies, ACL Digital brings in competitive advantage, innovation, and fresh perspectives to business challenges. With a multi-cultural and transnational talent and as part of the ALTEN Group comprising over 50000+ employees spread across more than 30 countries, it promotes a collaborative knowledge-building environment

Similar Jobs

Kroll Logo Kroll

Associate Manager, Investigations, Diligence and Compliance - Specialist

Big Data • Security • Software • Analytics • Cybersecurity
In-Office
5 Locations
5001 Employees
70K-150K Annually

Kroll Logo Kroll

Senior Manager, Investigations, Diligence, and Compliance - Specialist

Big Data • Security • Software • Analytics • Cybersecurity
In-Office
5 Locations
5001 Employees
90K-200K Annually
In-Office
02140, Cambridge, MA, USA
28-28 Hourly

Johnson & Johnson Logo Johnson & Johnson

Sr. Source Regulatory Compliance Specialist

Healthtech • Biotech • Pharmaceutical • Manufacturing
In-Office
4 Locations
143612 Employees

Similar Companies Hiring

Amplify Platform Thumbnail
Fintech • Financial Services • Consulting • Cloud • Business Intelligence • Big Data Analytics
Scottsdale, AZ
62 Employees
Standard Template Labs Thumbnail
Artificial Intelligence • Information Technology • Software
New York, NY
25 Employees
Golden Pet Brands Thumbnail
Digital Media • eCommerce • Information Technology • Marketing Tech • Pet • Retail • Social Media
El Segundo, California
178 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account