Quality Assurance Associate Position Available In Middlesex, Massachusetts

Job Title:

Quality Assurance Associate Job Description The Quality Assurance Associate will support floor QA issues within the manufacturing suite, mitigate gaps and risks for all quality and GMP processes, run investigations for deviations, change controls, CAPAs, and out-of-specifications, and review and author Standard Operating Procedures (SOPs). Responsibilities Support floor QA issues within the manufacturing suite. Mitigate gaps and risks for all quality and GMP processes. Conduct investigations for deviations, change controls, CAPAs, and out-of-specifications. Review and author SOPs. Essential Skills Proficiency in quality assurance and document control. Experience with batch record reviews and CAPA. Understanding of compliance and audits. Knowledge of quality systems management. Additional Skills & Qualifications Bachelor’s degree with 3-5 years of experience. Experience supervising or managing direct reports. Support GMP requirements and compliance. Familiarity with c

GMP, FDA

regulations (21 CFR Parts 211, 212), and ICH. Work Environment The role is part of a team of 3-4 individuals, operating on a 1st shift, Monday through Friday, in a business casual environment. Occasional weekend work may be required. The company values hard-working individuals and great team players. Enjoy contractor perks including participation in company events, fully stocked kitchens, company-provided lunch twice a week, and access to an on-site gym open 24/7.