| Framingham, MA
$30-35/hr.
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::