Immediate opportunity for a QC Microbiology Associate I to join a leading biotechnology and pharmaceutical company specializing in RNA therapeutics, located in Marlborough, MA.
In this role, you will play a key part in the commissioning and qualification of the company's new Marlborough facility. Responsibilities include performing routine environmental monitoring, critical utility sampling (WFI and gas), and gowning.
Shedule/Shift: 1st shift, Mon.-Fri.
location: Marlborough, Massachusetts
job type: Contract
salary: $30.00 - 36.10 per hour
work hours: 8 to 4
education: No Degree Required
responsibilities:
- Perform routine environmental monitoring and critical utility sampling activities.
- Conduct analysis of water samples to include TOC, Conductivity, Bioburden, and Endotoxin.
- Conduct process gasses testing for Total particulates, Viable Air, Hydrocarbons and Dewpoint.
- Perform routine testing in support of manufacturing processes to include bioburden, sterility, endotoxin, culture purity and cell stock identity.
- Prepare and ship contract laboratory testing samples including those intended for microbiological identification.
- Perform general laboratory support activities including equipment maintenance and housekeeping.
- May participate in equipment and method qualifications, validations, and method transfers.
- Perform data entry utilizing good documentation practices.
- Support initiation/closure of quality system records such as environmental monitoring excursion notifications and deviations.
- Write/revise standard operating procedures.
- Additional duties as may be assigned from time to time
qualifications:
- Bachelor's degree (BA / BS) in STEM field, OR five (5) years Quality Control experience in a cGMP organization with a focus in Microbiology.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
- This position is site-based, requiring you to be onsite full-time. This position is not eligible for remote work.
- Experience in a GMP QC laboratory setting, focusing on microbiology.
- Hands-on experience with particle counters, viable air samplers, and gas equipment.
- Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP, eQMS).
- Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
- Strong written and oral communication skills and organizational abilities.
- Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
skills: Quality control, MS-WORD, Biology, Microbiology, GMP (Good Manufacturing Practice), Environmental Sampling
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.
