What You’ll Do: We are looking for an experienced and detail-oriented Quality Operations (QA) Specialist to play a critical role in supporting our growing Quality Assurance organization. Reporting to the VP, Quality, The QA specialist works directly with Quality Assurance Managers and supports and assesses operational needs and activities to successfully achieve quality goals and metrics across multiple quality functions. 

Responsibilities:

• Assist in the maintenance and tracking of all Quality related documentation including, but not limited to: SOPs, Protocols, Deviations, Investigations, CAPAs, Change Controls, etc.
• Assist in maintaining all investigation and CAPA related documentation as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs, cGCPs and cGMPs.
• Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s electronic Quality System.
• Actively participate in the review and approval of batch record documentation (master and executed) to support quality release of drug product in a timely manner.
• Assist in change control management program and document archival.
• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
• Perform quality review of documentation and processes.
• Assists with SOP revision and participates in inspections, as needed.

Qualifications:

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, Pharmacy) or a related field.
• Minimum of 6 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry without degree.
• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred.
• Familiar with GxP, FDA, ICH, and OSHA requirements.
• Familiar with Microsoft Office applications (Word, Excel, etc.).
• Must have strong organizational skills and exceptional attention to detail.
• Able to work independently and as part of a team.
• Communication Proficiency, Problem Solving/Analysis, Results Driven,  Technical Capacity,  Thoroughness

Location: This is a hybrid position with three days on site at our office in Burlington, MA.

Travel: Minimal travel is expected for this position.