Quality Control Analyst I, Microbiology
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location: Norwood, Massachusettsjob type: Contract
salary: $30 - 37 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:In this role, you will support cGMP microbiology methods for QC raw material, plasmid, drug substance, Stability and finished product testing for mRNA products produced at the company's manufacturing facility. This individual will contribute to non-testing projects and activities as needed example document certification, monthly biosafety cabinet cleaning etc.
- Execute compendial microbiological testing, and other methodologies as needed.
- Receive Environmental Monitoring Plates into MODA, Incubate, Microbial identification,
- Support testing for in-process samples, drug substance and drug product, including generation of testing data to support clinical studies.
- Assist in enumeration of test plates, review EM data, etc.
- Perform general laboratory support activities including reagent preparation, equipment maintenance, weekly and monthly cleaning of the BSCs, Document Certification, archival etc.
- Stock and perform inventory of lab supplies.
- Establish and maintain a safe laboratory working environment.
- Additional duties as may be assigned from time to time
- BS degree in a relevant scientific discipline with a minimum of 1-2 years of Quality Control experience
- 1-2 years prior hands on experience with environmental monitoring.
- 1-2 years prior hands on experience with aseptic technique.
- 1-2 years prior hands on experience working inside of a clean room.
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way.
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, or equivalent software)
- Strong written and oral communication skills.
- Strong organizational skills
- Ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment efficiently and independently.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- MS degree in a relevant scientific discipline with 0-1 year of Quality Control experience in a cGMP organization
- 1-2 years prior hands on experience with bioburden or endotoxin testing.
skills: Quality control, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.