The Quality Control Associate II will support cGMP QC activities for raw materials, drug substances, and finished products at the company's manufacturing facilities. This role includes performing perform routine quality control Microbiology testing and ensuring compliance with cGMP standards. The position requires collaboration with cross-functional teams to maintain quality and efficiency in QC operations.
location: Norwood, Massachusetts
job type: Contract
salary: $35.00 - 40.65 per hour
work hours: 7 to 3
education: Bachelors
responsibilities:
- Conduct QC Microbiology routine testing including but not limited to bioburden, endotoxin, sterility, TOC, and enumeration.
- Maintain and troubleshoot laboratory equipment and manage QC lab supplies.
- Write, revise, and maintain SOPs, protocols, and reports.
- Participate in quality systems records such as deviations, change controls, CAPAs, and non-conformance investigations.
- Perform general laboratory support activities including equipment maintenance and housekeeping.
- Ensure compliance with cGMP documentation and regulatory guidelines.
- Establish and maintain a safe laboratory working environment.
- Provide support during internal and vendor audits and collaborate on continuous improvement initiatives.
qualifications:
- STEM degree with 2-3 years' of experience in a cGMP laboratory setting, with hands-on experience in microbiology techniques.
- 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 handle multiple projects in a fast-paced environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
skills: Microbiology, Laboratory Information Management Systems (LIMS), Aseptic Technique, Good Manufacturing Practices (GMP)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.
