Title:  Associate Compliance

Job Summary

The Associate Compliance provides support with the assessments of the Global procedures as well as site procedures to ensure compliance with current Good Manufacturing Practices (cGMP) and Quality Management System standards. Also compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.

Area Of Responsibility

· Support and assist the QA Complaint Coordinator and the QA Compliance Head on the evaluation and

investigation of product quality complaints.

· Work directly on technical investigations relating to Product Quality Complaints. Document the evaluation and investigation of Product Quality Complaints within the Trackwise system.

• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• 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
• Management of site to corporate communication on all of the Global SOPs and Billerica site SOPs.
• Requires excellent communication and organizational skills to lead meetings and work with site cross-functional teams
• Driving the implementation of gap assessments and meeting critical corporate site timelines.
• Also understanding of the Quality systems regulations and CAPA, change control requirements.
• Understanding of technical writing.
• Manage electronic Quality Management System (Trackwise)
• Implement electronic Quality Systems, such as QMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Develop presentation monthly for QRB meeting based on assessments of Global Procedures, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
• Drive projects to improve the Global Procedures for compliance through Trackwise (TW), efficiency, or corporate needs
• Author/revise standard operating procedures (SOPs) as required
• Other duties as assigned

Work Conditions:

• Office

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
• Talk or hear
• Close vision
• Computer/office machines
• Lift up to 10 lbs.

Some travel outside of company facility required

Travel Estimate

• Up to 5%

Education and Job Qualification

• BS in any scientific field
• Superior internal and external customer service/people skills
• Ability to manage multiple responsibilities and projects in a fast paced environment, while performing in an efficient manner.
• Experience working with cross functional Teams.

Experience

• Minimum 4-5 years related experience in a pharmaceutical manufacturing environment
• Working knowledge of cGMPs, GLPs
• Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
• Strong working knowledge of MS Office software
• Preferably knowledge to handle EDMS, LMS, Master Control and Trackwise system.
• Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture