QC Scientist I

Job Description

Location:: Framingham, MA

Visa Status:: Any work visa (Visa sponsorship available)

Salary::$30-35/hr.

Duration::

Job Description:

Duties: 
Quality Control Validation Scientist I is responsible for the qualification activities, following SOPs and regulations including Data Integrity,  related to one or more of the following areas: IQ, OQ, PQ, and requalification.
 
Core Responsibilities:
Perform qualification in a cGMP biotech manufacturing facility managing multiple complex qualification projects and providing technical assistance to less experienced team members.
Write, review, and approve qualification protocols and reports as well as execute the protocol.  Resolve protocol discrepancies and deviations.
Evaluates new technologies platforms for implementation in the QC Laboratories.
Ensure GMP compliance of all activities performed.
Represent QC Validation in internal and external audits as required.
Ensure appropriate facility support and provide technical expertise with regards to equipment.
Review standard operating procedures.
Maintain a positive relationship and network effectively across sites and organizations.
Provide project oversight and participate in cross-functional teams.
Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines.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:
Perform other additional job-related duties as required.

Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Genzyme a great a 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.

Skills:  
Ability to present technical data.
Ability to work independently on scientific projects.
Scientific technical writing ability authoring and reviewing SOPs, qualification protocols and technical reports.
Experience troubleshooting of assay and equipment issues
Knowledge of Validation Lifecycle Approach.
 
Keywords:
Education:
Bachelor’s degree in Life Sciences discipline and 5  years of experience in cGMP lab environment, or
Master’s degree in Life Sciences discipline and 3 years’ experience in cGMP lab environment.
Ph.D. in Life Sciences discipline and 0-3 years’ experience in cGMP lab environment

Skills and Experience:
Required Skills: 
CGMP
DATA INTEGRITY
LIFE SCIENCES
EQUIPMENT VALIDATION
Additional Skills:
QUALITY CONTROL
SOPS
GMP
LOCKOUT/TAGOUT
PROJECT OVERSIGHT
SAFETY PROCEDURES
TECHNICAL ASSISTANCE
Languages:
English
        Read
        Write
        Speak
Minimum Degree Required: Bachelor's Degree

Qualification::