Quality Systems Specialist

What You’ll Do: The Quality System Specialist will support the continued development and manufacturing of MapLight products.  Reporting to the Senior Manager, Quality Systems, QA, this role plays a key role in supporting the GMP Quality Management System to ensure compliance with applicable GxP regulations, company policies, and standard operating procedures. This position focuses on maintaining robust electronic quality systems, including (but not limited to) managing controlled documentation, archiving, and training

Responsibilities:

• 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.

Qualifications:

• 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.