Job Description

🌟 We're Hiring: Quality Control Analyst III! 🌟

We are seeking a detail-oriented and experienced Quality Control Analyst III to ensure our products meet the highest standards of quality and compliance. The ideal candidate will have extensive experience in quality testing, data analysis, and regulatory requirements to maintain excellence in our manufacturing processes.

📍 Location: Norton, MA

What You'll Do:

• Perform analytical/microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs

• Support weekend laboratory operations (Analytical, Microbiology, Raw Materials)

• Maintain training records , adhere to testing schedule , and ensure timely completion of assignments

• Maintain laboratory equipment and inventory , prepare reagents and samples

• Review data timely ; qualify as a data reviewer

• Perform role-specific tasks (raw material processes, SAP transactions, environmental monitoring, in-process testing)

• Revise/update controlled documents (SOPs, work instructions, test methods)

• Adhere to internal standards, SOPs, GMP, GLP, ICH guidelines

• Identify and suggest process improvements

• Collaborate with QC and cross-functional teams

• Pursue ongoing training in QC techniques, TOQ operations, and compliance

• Assist in technical documentation for regulatory submissions, ensuring accuracy

• Support audits, inspections, and inspection readiness

• Collaborate with CMC Development, Manufacturing, MTS, Materials Management, Quality Assurance to align with business goals

What We're Looking For:

• B.S. in Chemistry, Biology, Biochemistry , or related scientific field

• Pharmaceutical/Biotech industry experience with 4 years in a GMP Quality Control function or equivalent, relevant industry experience
  

• Experience in method transfer/implementation ; knowledge of method lifecycle management

• Technical writing skills (preferably investigations)

• Proficient in data analysis and interpretation with strong attention to detail

• Problem-solving skills with experience in investigations and CAPA

• Strong organizational skills; able to manage multiple tasks autonomously

• Excellent communication and teamwork skills

• Proficiency in LabWare LIMS, Excel, Word, PowerPoint preferred

Ready to make an impact? 🚀 Apply now and let's grow together!

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