- Requesting, sampling, and peer review of raw materials.
- Sample coordination including cross functional collaboration with internal and external labs.
- Train and perform testing for methods including HPLC, Bioanalyzer, osmolality, pH, conductivity, TruScan RM spectroscopy, appearance, and dimensional verification.
- Inspect raw material retain samples.
- LIMS (LabVantage) sample logging and result entry.
- Raw material and consumable component inspection and release.
- Clean room gowning and aseptic techniques.
- Managing/stocking of QC lab supplies and routine lab cleaning.
- Complete and maintain cGMP documentation for work performed.
- Participate in supporting quality systems records such as deviations, change controls, CAPAs and investigations
- Establish and maintain a safe laboratory working environment.
- Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Bachelor's degree in a relevant scientific discipline.
- 1-2 Years with BS or 4+ experience in GMP QC laboratory setting.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
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QC Associate Raw Materials - Norwood, United States - Randstad Life Sciences US
Description
Associate II, Quality Control Raw Materials
6 Months- likely to go much longer
Norwood, MA
Max PR: $33 an hour
M-F, 1st shift
Job Summary
The individual in this role will perform QC Raw Material activities in support of GMP Manufacturing and further support special projects as assigned. This position will be 1st shift working Monday through Friday.
Job Responsibilities
Education & Qualifications
