Quality Systems Specialist

• →Manage the full lifecycle of controlled documents, including creation, revision, approvals and archival within the electronic Quality Management System (ZenQMS).
• →Ensure that controlled documents, such as SOPs, Policies, etc are accurate, current and compliance with regulatory and internal requirements.
• →Collaborate/Coordinate workflows with internal stakeholders to ensure timely completion and alignment of documentation / metadata with procedural requirements.
• →Provide day-to-day support to employees on document control and quality system processes.
• →Author/support the creation, review, and modification of Standard Operating Procedures (SOPs), Work Instructions (Wis), and supporting documentation.
• →Support QA onboarding of all employees/contractors
• →Support management of deviation, CAPA, change control within QMS.

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field or equivalent work experience.
• Minimum of 5 years of experience in the biotechnology or pharmaceutical industry
• Understanding of FDA, EMA, and ICH guidelines and regulations. Familiarity with GCP, GMP, and GLP standards.
• Excellent attention to detail, organizational, communication, and problem-solving skills, ability to manage multiple priorities in a dynamic environment. Strong knowledge of Microsoft Office Suite.
• Experience with electronic quality management systems (eQMS) is strongly preferred.

Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA.