- 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.
- 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.
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Framingham, Massachusetts
job type: Contract
salary: $30.00 - 35.71 per hour
work hours: 8 to 4
- 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.
- 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.
- Experience in GMP lab environment.
- Experience with lab based data management systems.
- Experience in a quality control lab.
Special Working Conditions:
- Work in a laboratory with minimal use of chemicals.
- Ability to lift 10 lbs.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.