Associate I, Quality Control Job Summary
- We are seeking a 2 nd shift Quality Control Sample Management Associate I based at our Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay. Analytical Development and Drug Product Development labs. Also, this individual may support special projects as assigned.
Education & Qualifications
- Sample coordination including cross functional collaboration with internal and external labs
- Receipt, processing, distribution and shipment of the following sample types:
- In-Process, DS, Formulation and DP
- Equipment cleaning
- Raw Materials
- Coordinating domestic and international sample shipments
- Communication with external Contract Test Labs (CTLs)
- Inspect product and raw material retention samples
- LIMS (LabVantage) sample logging and result entry
- AQL visual inspection of drug product
- May perform HPLC (AEX) and NaOH plate reader based assays in support of manufacturing process stat testing as needed
- Stability program support
- Controlled temperature unit management, maintenance and troubleshooting
- Clean room gowning
- Managing/stocking of QC lab supplies
- 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
- Minimum experience/education required: 5+ years in a cGMP laboratory setting or Bachelor's degree in a relevant scientific discipline with 1+ years in a cGMP laboratory setting preferred
- Minimum knowledge required: cGMPs
- Minimum skills required:
- Technical writing
- Proficiency with Microsoft Office Programs
- Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, EDMS, CMMS, LMS)
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
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.