Title: Associate II, Quality Control Raw Materials
Reports to: Associate Director, Quality Control
Function/Department: Quality Control
Regulatory Relevance: GxP and GMP
Location: Norwood, MA
1st shift M-F
3rd shift Wed-Sat
The Role:
Reporting to the Associate Director of Quality Control, is seeking a Quality Control Raw
Materials Associate II based at their Norwood, MA site. 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 1 st shift working Monday through Friday.
Key Responsibilities: • 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.
Required Background: • Education: Bachelor's degree in a relevant scientific discipline. • Experience: 1-2 Years with BS or 4+ experience in GMP QC laboratory setting.