QC Analyst II - Microbiology

Job DescriptionPOSITION: QC Analyst 2- Microbiology
SHIFT: Mon-Fri 1st shift 7am-330pm
Department Description:
Quality Control Microbiology (QCM) is responsible for testing intermediate production
samples, final product samples, and environmental samples to demonstrate that all
products meet the standard requirements for CGMP operations. Additional functions
include raw material testing, stability testing, assay transfers, and qualification of
instrumentation. Quality Control is also responsible for assisting in site wide studies and
projects.

Position Summary:
This position is responsible for performing routine and complex testing of in-process
samples and final products in accordance with SOPs and relevant procedures for method
development, qualification, validation, method transfer, product release, stability, and
process validation and investigations.
Responsibilities include:
Perform laboratory assays in support of method development, qualification, validation,
method transfer, product release, stability, and process validation and investigations.
Perform maintenance on complex laboratory equipment.
Review data for compliance to procedures and specifications.
Calculate and evaluate results.
Make detailed observations in support of Alert, Action and OOS result investigations.
Participate in writing and revising SOPs.
Assists in the qualification of new controls, standards and reagents
Effectively demonstrate an understanding of and work in compliance with CGMPs.
Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.
Actively participate in problem solving meetings with senior staff members and
suggest process improvements.
Independently work under supervision and direction.

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:
Being a Subject Matter Expert (SME)/Trainer/Coach to other analysts within the
laboratory.
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 or equivalent and 2 + years laboratory experience.
Master's degree or equivalent and 0-1 year experience.
Basic knowledge (i.e. 1-2 years experience) in the required method platform (e.g.
Bioburden, TOC, Endotoxin, Water Chemistry, ELISA).
Attention to detail, and able to maintain accurate records with excellent proofreading
skills
Able to communicate effectively with others
Able to work effectively both independently and as a member of a team
Proficient with Microsoft Office tools such as: Word, Excel & Powerpoint.

PREFERRED QUALIFICATIONS:
Experience in GMP lab environment.
Experience with lab based data management systems.
Experience in a quality control lab.

Special Work Conditions:
" Work in a laboratory with minimal use of chemicals.
" Ability to lift 10 lbs.