The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, 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 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
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 chemistry or related 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
Minimum 6-8 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 knowledge of instrumental and wet analytical chemistry
Strong knowledge of microbiology testing
Strong working knowledge of MS Office software
Preferably knowledge to handle SAP, EDMS, LMS, Master Control etc…
Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
