Sr. Associate of Compliance

Billerica, MA

PERM

Responsibilities:

• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
• Work directly on technical investigations relating to Product Quality Complaints
• Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
• Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
• Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
• Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
• Manage electronic Quality Management System (TrackWise)
• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
• Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
• Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
• Author/revise standard operating procedures (SOPs) and test methods, as required

Job Type: Full-time

Salary: $100,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Billerica, MA 01821: Reliably commute or willing to relocate with an employer-provided relocation package (Required)

Work Location: One location

Speak with the employer
+91 (978) 966-1607

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