Job Description
Job Description
Ready to Make an Impact in Biopharm Quality Control?
Client is seeking a contract role in Quality Control Raw Materials Associate II based at their Norwood, MA site and surrounding locations. The individual in this role will perform QC Raw Material activities in support of GMP Manufacturing. Also, this individual may support special projects as assigned. This role is 1st shift, Monday to Friday.Join a high-performing team dedicated to advancing life-saving therapies! We are seeking a detail-oriented Quality Control Associate II to support cGMP QC testing for raw materials, drug substances, and finished products at our state-of-the-art manufacturing facility.
In this hands-on, on-site role, you will execute and troubleshoot core analytical methods, drive method transfers, and ensure absolute compliance with cGMP standards. If you excel in a fast-paced environment and want to apply your testing expertise directly to patient safety, this opportunity is for you!
The Role The Quality Control Associate II will support cGMP QC testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards. This is an on-site position.Here’s What You’ll Need (Basic Qualifications) Education: BA/BS DegreeExperience: STEM degree with 3-5 years’ of experience in a cGMP laboratory setting, with hands-on experience in mammalian cell culture, cell based and potency assays, ELISA, molecular biology, and Protein Analysis.INTERESTED? APPLY NOW! THESE POSITIONS FILL FAST!
salary: $36 - $36.11 per hour
shift: First
work hours: 8 AM - 4 PM
education: Bachelors
Responsibilities
Here’s What You’ll Do:
- Requesting, sampling, releasing and shipping of raw materials
- Sample coordination including cross functional collaboration with internal and external labs
- Train and perform testing for methods including Bioanalyzer, osmolality, pH, conductivity, TruScan
- RM spectroscopy, appearance and dimensional verification
- Supporting domestic and international sample shipments
- Inspect product and raw material retain samples
- LIMS (LabVantage) sample logging and result entry
- Raw material and consumable component inspection and release
- Controlled temperature unit management, maintenance and troubleshooting
- Clean room gowning and aseptic techniques
- Managing/stocking of QC lab supplies and routine lab cleaning
- Write/revise SOPs, protocols and reports
- Complete and maintain cGMP documentation for work performed
- Participate in authoring quality systems records such as deviations, change controls, CAPAs
- Support non-conformance investigations
- Establish and maintain a safe laboratory working environment
Skills
- Quality Control
- Quality Assurance
- cGMP
- GMP
- raw materials
- Drug Substance
- ELISA (1 year of experience is required)
- mammalian cell culture
- molecular biology
- Years of experience: 2 years
- Experience level: Experienced
Qualifications
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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.